BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 11633566 · Received April 8, 2021

    Report

    Report Number
    2916596-2021-01779
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 30, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE RUBBER HOUSING ON THE MOBILE POWER UNIT (MPU) PATIENT CABLE CONNECTOR BEING LOOSE WAS CONFIRMED VIA ANALYSIS OF THE RETURNED MPU (SERIAL NUMBER: MPU-33584). THE RETURNED MPU WAS EVALUATED AT THE EUROPEAN DISTRIBUTION CENTER. VISUAL INSPECTION OF THE RETURNED MPU REVEALED THAT THE RUBBER CASING ON THE MPU PATIENT CABLE CONNECTOR WAS LOOSE. THE MPU WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED. THE OBSERVED DAMAGE TO THE PATIENT CABLE DID NOT AFFECT THE FUNCTIONALITY OF THE UNIT DURING ANALYSIS. THE DAMAGED PATIENT CABLE WAS REPLACED. AFTER REPLACING THE PATIENT CABLE, A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND THE UNIT PASSED ALL TESTS WITHOUT ANY ISSUES. THE REPLACED MPU PATIENT CABLE WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. PPE EVALUATION OF THE RETURNED PATIENT CABLE REVEALED THAT THE RUBBER CASING ON THE CONNECTOR WAS LOOSE. THE MPU PATIENT CABLE WAS INSTALLED INTO A TEST MPU AND CONNECTED TO A TEST SYSTEM CONTROLLER. THE CONTROLLER POWER CABLES WERE ABLE TO BE FULLY THREADED TO THE MPU PATIENT CABLE WITHOUT ANY ISSUES. THE TEST SYSTEM CONTROLLER WAS THEN CONNECTED TO A MOCK CIRCULATORY LOOP AND OPERATED THE SYSTEM WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MPU PATIENT CABLE WAS MANIPULATED BY HAND. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. INCIDENTAL FINDINGS: DAMAGED RED BATTERY STRAP. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE MOBILE POWER UNIT (MPU), SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR EQUIPMENT¿ EXPLAIN HOW TO PROPERLY CARE FOR THE EQUIPMENT, INCLUDING THE MPU PATIENT CABLE. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ "CARING FOR THE EQUIPMENT" DESCRIBES HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU PATIENT CABLE. SECTION 10, ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE MPU PATIENT CABLE FOR DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CABLE¿S RUBBER CONNECTOR ENCASING WAS LOOSE. NO PATIENT WAS INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534994 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION L107758 7003944

    Patients

    Seq Age Sex Outcome Treatment
    1