Alerts and notifications older than one year can be found below for your reference.
2017 Alerts & 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:
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: Click Here
Controllers and DC Adapter: Click Here
2016 Alerts & Notifications
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:
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: Click Here
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):
The CDC's new heater-cooler web page:
*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:
2015 Alerts & Notifications
October 25, 2015
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:
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.