Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, has issued a medical device safety alert concerning the HeartMate 3 Modular Cables [Catalogue Number: 106525INT and 106525] and HeartMate 3 Left Ventricular Assist System (LVAS) Kit [Catalog Number: 106524INT and 106524], manufactured by Abbott.

The manufacturer is informing physicians and VAD coordinators that it has received reports of the HeartMate 3 modular cable being incorrectly inserted into the controller by patients during controller exchange. Per the Instructions for Use (IFU), exchanges are required to be performed by medical professionals in the hospital setting; however, patients and their caregivers may need to conduct the exchange in an emergency situation and are therefore trained on the procedure. If the modular cable is incorrectly inserted at 180 degrees from the proper orientation, there is potential for erroneous electrical contact to be made, which may cause a blown fuse, confusion for the patient, and the controller to alarm with "Controller Fault." In this case, although a physical connection appears to have been made, there is no electrical connection to power the pump.

According to the manufacturer, there is currently a one percent worldwide complaint rate associated with reports of the modular cable being inserted 180 degrees from the proper orientation. The incorrect connection, as a result of patient exchanges outside of the hospital setting, may result in serious injury or death.

The manufacturer gives the following recommendations for patient management:-

In the event of a "Controller Fault" alarm:

• As with any system controller exchange away from the hospital, the patient must have a caregiver present and all labeling instructions must be followed, including calling the hospital contact.
• The patient should make an exchange to their backup controller paying specific attention to the markings on the controller and driveline.

The following instructions should be reinforced for all HeartMate 3 patients during their next clinic visit:

• A review of the HeartMate 3 Patient Handbook, which instructs patients to contact the hospital if the System Controller alarms and displays "Call hospital contact," and reinforce that System Controller exchanges are recommended to be performed in the hospital.
• If a system controller exchange must be done outside the hospital, ensure that the patient understands the need for having a caregiver present during System Controller exchange and that all labeling instructions are followed, including calling the hospital contact.
• Train patients on the process for exchanging controllers including the proper alignment and insertion of the modular cable, as outlined in the Clinic Visit Safety Checklist in the HeartMate 3 IFU.

The manufacturer's field personnel will be performing re-training of all sites on the proper method of connecting the controller cable according to the IFU.

For details, please refer to the following MHRA website: 
https://www.gov.uk/drug-device-alerts/field-safety-notice-02-to-06-december-2019

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 10 December 2019