BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 12337864 · Received August 18, 2021

    Report

    Report Number
    2916596-2021-04678
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 18, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DAMAGED MODULAR CABLE WAS CONFIRMED VIA THE RETURNED MODULAR CABLE (LOT NUMBER 170071). THE RETURNED MODULAR CABLE CONTAINED A RIP IN THE POLYURETHANE JACKET, CONFIRMING THE REPORTED EVENT. THE MODULAR CABLE WAS FUNCTIONALLY TESTED AND PASSED ALL STEPS WITHOUT ISSUE. THE MODULAR CABLE WAS THEN TESTED BY MEASURING THE RESISTANCE OF THE INDIVIDUAL WIRES USING A DIGITAL MULTIMETER AND NO ISSUES WERE OBSERVED. THE RETURNED MODULAR CABLE WAS THEN CONNECTED TO A KNOWN WORKING TEST SYSTEM CONTROLLER AND PUMP WITHOUT ISSUE. THE MODULAR CABLE WAS MANIPULATED BY HAND DURING TESTING WITH NO ISSUES OR ATYPICAL ALARMS OBSERVED. NO FURTHER TESTING WAS COMPLETED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THERE WAS ALSO AN INCIDENTAL FINDING OF FLUID INGRESS UNDERNEATH THE POLYURETHANE JACKET THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MODULAR CABLE WAS SHIPPED TO THE CUSTOMER ON 05MAY2016. THE HEARTMATE III PATIENT HANDBOOK SECTION 4 "LIVING WITH THE HEARTMATE 3" CONTAINS INFORMATION REGARDING HOW TO CLEAN, CARE FOR THE DRIVELINE, AND CONNECT IT PROPERLY. THIS SECTION INSTRUCTS THE USER TO INSPECT THE MODULAR CABLE IN-LINE CONNECTOR FOR SIGNS OF DAMAGE, SUCH AS CRACKING, FRAYING, WEAR, EXPOSED WIRES, SHARP BENDS, OR KINKS. CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." THE HEARTMATE III PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE III LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE HEARTMATE III PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTIONS THE USER 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S MODULAR CABLE OUTER LAYER WAS DAMAGED AND REQUIRED EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236586 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525INT 170071 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR