Medical device manufacturer, HeartWare (a part of Medtronic), has issued a medical device safety alert concerning its HeartWare HVAD System Controller/ Controller Kits [Model Numbers: 1403, 1407, 1420; Serial Number Range: CON300175 – CON320540].

The manufacturer has become aware that the controller units in the range mentioned above may not meet the labeled standard for protection against water or fluid ingress. Some units have the potential to develop hairline cracks at the power ports of the controller housing. The cracks may allow for water or fluid ingress if the patient does not follow the Instructions for Use and the Patient Manual, including use of a water-resistant shower bag to help protect the unit. This can lead to varying degrees of controller malfunction, including pump stop.

According to the manufacturer, the cracks were found during manufacturer inspection of product under 10 x magnifications and are not visible without magnification. The root cause was determined to be a latent interaction between the materials used in the housing unit and the nitrile rubber gasket of the power port connector.

The manufacturer recommends the following Patient Manual instructions should be reinforced:

• Patients currently supported by the HVAD System should follow all instructions in their Patient Manuals regarding water or fluid avoidance, which remain unchanged, and understand the importance of always using a shower bag when showering.
• If a patient encounters a situation in which their HVAD System Controller is exposed to water or fluid outside of conditions described in the IFU and Patient Manual, the patient should be advised to contact his/her VAD coordinator.
• If further assistance is needed, clinicians should contact their local supplier.

The manufacturer and the Independent Practitioner Quality Panel do not recommend proactive controller exchanges as a result of this potential issue.

The manufacturer has since resolved this issue in the manufacturing process, and all newly distributed Controller units are no longer susceptible to this materials interaction. No other HVAD System components are susceptible to the issue.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 31 August 2018