BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 16397494 · Received February 17, 2023

    Report

    Report Number
    2916596-2023-01052
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    February 12, 2023
    Report Date
    March 31, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: SERIAL NUMBER WAS INADVERTENTLY ADDED IN INITIAL REPORT AND IS NOT APPLICABLE FOR THIS DEVICE. SECTION D6A: IMPLANT DATE WAS INADVERTENTLY ADDED IN INITIAL REPORT AND IS NOT APPLICABLE FOR THIS DEVICE. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE COMMUNICATION FAULT ALARM WAS CONFIRMED VIA EVALUATION OF THE SUBMITTED LOG FILES AND THE RETURNED MODULAR CABLE (LOT NUMBER: 152364). THE SUBMITTED EVENT LOG FILE CONTAINED APPROXIMATELY 5 DAYS OF DATA (08FEB2023 TO 12FEB2023 PER TIMESTAMP). BEGINNING AT 12:02:50 ON 12FEB2023, A DRIVELINE COMMUNICATION FAULT ALARM WAS OBSERVED. THIS ALARM WAS COINCIDENT WITH AN INTERNAL FAULT INDICATING THAT THE COM A SIGNAL HAD BEEN COMPROMISED. THIS ALARM DID NOT IMPACT THE ABILITY OF THE CONTROLLER TO OPERATE THE PUMP, AS THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT WITHOUT ISSUE THROUGHOUT THE DATA. THE MODULAR CABLE WAS OBSERVED TO BE HEAVILY DAMAGED UPON ARRIVAL, MISSING ITS INLINE STRAIN RELIEF AS WELL AS THE MAJORITY OF ITS OUTER JACKET. THE INNER WOVEN LAYER WAS ALSO OBSERVED TO HAVE BEEN DAMAGED. DURING FUNCTIONAL TESTING OF THE RETURNED CABLE, THE DRIVELINE POWER FAULT ALARM WAS REPRODUCED. THE CABLE UNDERWENT RESISTANCE TESTING AND DID NOT PASS DUE TO INCREASED RESISTANCE OF ITS GREEN INNER WIRE, WHICH PERTAINS TO THE COM A SIGNAL. THE RESISTANCE OF THIS WIRE WAS OBSERVED TO FLUCTUATE GREATLY WHEN THE CABLE WAS MANIPULATED BY HAND IN A PARTICULAR AREA. THE LAYERS OF THE CABLE WERE REMOVED ONE AT A TIME IN THIS AREA AND THE GREEN WIRE WAS OBSERVED TO HAVE BEEN SEVERED. THE ROOT CAUSE OF THE OBSERVED DRIVELINE COMMUNICATION FAULT ALARM WAS DETERMINED TO BE DAMAGE TO THE COM A WIRE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE MODULAR CABLE (LOT NUMBER: 152364) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. G - SECTION 5 "ALARMS AND TROUBLESHOOTING¿) DESCRIBES ALL ALARMS THAT MAY BE PRODUCED BY THE SYSTEM CONTROLLER, INCLUDING THOSE ASSOCIATED WITH DRIVELINE COMMUNICATION FAULT CONDITIONS, AND PROVIDES INSTRUCTIONS ON HOW TO APPROPRIATELY RESOLVE THEM. THE HEARTMATE 3 PATIENT HANDBOOK (REV. G - SECTION 6 "EQUIPMENT MAINTENANCE¿), DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE HEARTMATE 3 MODULAR CABLE. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE MODULAR CABLE WAS REPLACED DUE TO AN ACTIVE ALARM DRIVELINE COMMUNICATION FAULT. THE ALARM RESOLVED WITH THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137164 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 152364 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male