Alerts and Notifications

August 14, 2017

On August 7th, 2017, the U.S. Food and Drug Administration posted a safety recall from Datascope Corp./Maquet regarding CS100i, CSO100, and CS300 Intra-Aortic Balloon Pumps (IABP) manufactured before June 30, 2013.  The recall describes a valve failure that may prevent the balloon from inflating and deflating properly, and may result in immediate and serious adverse health consequences. 

This recall notice can be found by using the following link: 

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm570170.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 16, 2017

On May 5th, 2017, the U.S. Food and Drug Administration posted two (2) safety recalls from Medtronic Circulatory Support (formerly HeartWare Inc.) regarding components used with the HVAD system. One recall was an expansion of an existing recall for the VAD controllers and DC adapters. The other recall was a Splice Kit that is intended to repair external drivelines.

Splice Kit: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm556616.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Controllers and DC Adapter: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm556629.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

November 2, 2016

The Centers for Disease Control and Prevention (CDC) have recently updated their heater-cooler webpage to include frequently asked questions for hospitals regarding contaminated devices. The link to the new online resource can be found here:

https://www.cdc.gov/HAI/outbreaks/heater-cooler.html#questh

October 27, 2016

The U.S. Food and Drug Administration is holding an open conference call to update and inform heathcare providers on the M. chimaera associated with the 3T Heater Coller Systems. The conference call will take place on Tuesday, November 1st at 2:30 pm EST. Please refer to the following communication from the FDA for details:

The U.S. Food and Drug Administration (FDA) will host a conference call for health care providers at 2:30 PM ET on November 1, 2016 to discuss Mycobacterium chimaera (M. chimaera) infections associated with the use of the LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in U.S. patients who have undergone cardiothoracic surgeries and to review the recommendations from the FDA’s October 13, 2016 Safety Communication to help health care providers reduce the spread of infection related to use of this device.

A heater-cooler device is commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.

Please mark your calendars to join the FDA on Tuesday November 1, 2016 to discuss this public health concern. Representatives from the Centers for Disease Control and Prevention will assist with answering questions during the question and answer portion of the call.

We also encourage you to share this information with your members, fellow health professionals, and others who may find this announcement of interest.

Conference Call Information:

Date: November 1, 2016
Time: 2:30 – 3:30 Eastern Time
Dial-In: 1-800-475-0478, passcode HCD
International Callers Dial: 1-517-308-9373

To ensure you are connected, please dial-in 10 minutes prior to the start of the conference call. A replay of the briefing will be available one hour after the call ends until December 1, 2016. To hear the replay callers in the United States and Canada can dial 1-800-677-9149.  International Callers can dial 1-203-369-3408.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the FDA’s Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100, or by email at dice@fda.hhs.gov.

October 26, 2016

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the HeartWare HVAD Ventricular Assist Device Pump due to contamination causing electrical issues. This alert follows the initial recall notice on July 29, 2016, and the “Urgent Medical Device Recall Letter” to affected customers on August 17, 2016.

For further details on the recalled products affected (including serial numbers and manufacturing dates), please access the FSA Medical Device recall page at: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526212.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

October 19, 2016

The FDA and CDC have recently issued communications regarding Mycobacterium chimaera infections among patients who have undergone cardiothoracic surgery with the use of Stöckert 3T Heater Cooler Systems (3T) that were manufactured prior to September 2014. Investigation determined that the devices had been contaminated with M. chimaera at the manufacturer’s production and servicing facility in Germany (see October 13 Alert below).

In response to the October 13, 2016 communications from the FDA and CDC about the Stӧckert 3T Heater‐Cooler System (3T), manufactured by LivaNova PLC’s subsidiary Sorin Group Deutschland GmbH (“LivaNova”), LivaNova is establishing a new program to provide loaner Heater‐Cooler devices to certain existing 3T users. Under this program, each U.S. hospital that is actively using the the 3T Heater‐Cooler may request one loaner 3T device. LivaNova has decided to temporarily cease new sales of 3T Heater‐Coolers in the U.S. in order to redirect the maximum number of devices to the loaner program. However, availability is limited and the company will implement a prioritization process consistent with FDA and CDC recommendations to allocate available units. Additional information on the loaner program and product support is available by clicking the links below or on LivaNova’s website at www.livanova.sorin.com/3T.

Click the links below to view resources associated with this alert:

October 13, 2016

The Centers for Disease Control and Prevention (CDC) has issued a warning for both healthcare providers and patients about the potential risk of infection from contaminated devices used during cardiac surgery. This notification follows a recent investigation of confirmed cases of nontuberculosis mycobacterium (NTM) that might have been associated with the Stockert 3T heater-cooler device. The CDC is encouraging hospitals to take action by advising patients to seek care if they experience symptoms associated with these infections.

The CDC has provided various online resources to use for disseminating this information to your patients and care providers. In addition to the posting on the CDC's Morbidity and Mortality Weekly Report, communications to the public have been posted by the CDC through their social media channels. Below is the list of the newly updated resources:

The CDC Press Release (dated 10/13/16):
https://www.cdc.gov/media/releases/2016/p1013-contaminated-devices-.html

The CDC's new heater-cooler web page
https://www.cdc.gov/HAI/outbreaks/heater-cooler.html*
*This link includes a heater-cooler notification toolkit, including sample primary healthcare and patient notification letters.

CDC on Social Media:
Have you or a loved one had open-heart surgery, such as valve replacement, in the last few years? If so, this important safety information is for you. View the video "Important Information for Heart Surgery Patients" on CDC's Facebook, Twitter, or Youtube page.

For more information you can also visit the LivaNova site where you will find a list of frequently asked questions. AmSECT will continue to monitor and update the membership when new information emerges.

July 13, 2016

Medical error—the third leading cause in death in the US (article)

April 19, 2016

Terumo Cardiovascular Systems' Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assembly's Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor.

Terumo Cardiovascular Systems (Terumo CVS) received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices.

A communication from Terumo Cardiovascular Systems can be found here

March 4, 2016

Maquet Cardiopulmonary issued a voluntary recall involving products that were delivered prior to January 1, 2016 that possess the potential risk of exposure to endotoxins.  Products potentially affected include Quadrox Oxygenators, Rotaflow Centrifugal Pumps, and HLS advanced tubing sets.  While some products have resumed shipping and delivery, custom tubing packs will remain unavailable for an undisclosed period of time.

If your program uses these above-mentioned products, an urgent recall notice should have been delivered at your facility to the designated Risk Manager and/or the Manager of the Perfusion Department.

Additional information regarding Maquet Custom Tubing sets can be found here: http://www.maquet.com/us/alerts/maquet-cardiopulmonary-custom-tubing-packs/

A communication from the Extracorporeal Life Support Organization (ELSO) can be found here: https://www.elso.org/

January 13, 2016

Recently the Public Health Service of the Food and Drug Administration (FDA) recently issued a warning letter to the Sorin Group regarding the Stockert Heater Cooler 3T thermal regulator device. The complete letter can be viewed on the Inspections, Compliance, Enforcement and Criminal Investigations page found here:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm

On January 5th, LivaNova PLC provided an update on the FDA warning letter. The letter can be accessed on the LivaNova press release page found here:

http://www.livanova.com/investor-relations/pressreleases/news_release_2126429

October 25, 2015

The U.S Food and Drug Administration (FDA) has issued an important safety communication regarding Nontuberculosis Mycobacterium (NTM) infections associated with Heater-Cooler devices. According to the FDA, 25 Medical Device Reports (MDRs) were received in 2015 describing patients infected with NTM related to cardiothoracic surgery and heater-cooler contamination. The link to the safety alert can be found here:

FDA Medical Device Alert:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm

The Centers for Disease Control and Prevention (CDC) has been collaborating with the FDA and local and state health departments to further investigate heater-cooler contamination and patient NTM infections. Recommendations for health departments, healthcare facilities, healthcare providers, and patients can be found here:

.

Centers for Disease Control and Prevention:
http://www.cdc.gov/HAI/pdfs/outbreaks/CDC-Notice-Heater-Cooler-Units-final-clean.pdf

Clinical Perfusionists and healthcare providers are urged to follow the following recommendations:

  • Maintain strict adherence to the cleaning and disinfection instructions provided in the manufacturers device Instructions for Use (IFU)
  • Direct the heater-cooler exhaust vent away from the surgical field to reduce the likelihood of infection through aerosolization.
  • Establish a quality control program for cleaning and disinfection, including written procedures describing each maintenance step. This would also include the immediate removal of a heater-cooler device that displays any signs indicating water contamination.
  • Consider performing environmental sampling of operating room air and water when a heater-cooler is suspected of contamination.
  • Submit a report to the manufacturer and the FDA via MEDwatch if a heater-cooler device is suspected of infecting a patient.

The full list of recommendations and MedWatch Online reporting system can be accessed through the above-mentioned FDA Medical Device Alert link. The FDA has also provided links to several recent peer-reviewed journal articles describing cardiac surgical NTM infections.

AmSECT will continue to provide updates regarding this issue as they become available.

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An Active Member shall be any perfusionist active in the practice of extracorporeal circulation technology. There are also opportunities to become a Transitional Active Member for those less than a year removed from graduation from an approved accredited training program. Other options include; an Associate Membership, International Membership, Perioperative Blood Management Clinician Membership, and Student Membership.

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