BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 11879347 · Received May 25, 2021

    Report

    Report Number
    2916596-2021-02886
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    May 20, 2021
    Report Date
    August 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: INCIDENTAL FINDINGS: DAMAGE TO THE MPU¿S MAIN PCB. THE REPORTED EVENT OF DAMAGE TO THE MOBILE POWER UNIT (MPU) PATIENT CABLE CONNECTOR, MPU HANDLE, AND RED BATTERY STRAP WAS CONFIRMED VIA ANALYSIS OF THE RETURNED MPU. THE RETURNED MPU WAS EVALUATED AT THE EUROPEAN DISTRIBUTION CENTER. INSPECTION OF THE RETURNED MPU REVEALED THAT THE RUBBER CASING ON THE MPU PATIENT CABLE CONNECTOR WAS LOOSE. A CRACK WAS ALSO OBSERVED ON THE MPU HANDLE. IT WAS ALSO REVEALED THAT THE RED BATTERY STRAP WAS UNRAVELING. THE UNIT WAS FUNCTIONALLY TESTED AND FOUND TO OPERATE AS INTENDED DURING TESTING; THE OBSERVED DAMAGE TO THE PATIENT CABLE, HANDLE, AND RED BATTERY STRAP DID NOT AFFECT THE FUNCTIONALITY OF THE UNIT. THE DAMAGED PATIENT CABLE, HANDLE, AND RED BATTERY STRAP WERE REPLACED, AND PREVENTATIVE MAINTENANCE WAS PERFORMED. A FULL FUNCTIONAL CHECKOUT WAS THEN PERFORMED AND THE UNIT PASSED ALL STEPS OF THE TEST WITHOUT ANY ISSUES. THE SERVICED AND TESTED UNIT WAS RETURNED TO THE RENTAL POOL AFTER PASSING ALL TESTS PER PROCEDURE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THAT THE MOBILE POWER UNIT (MPU), SERIAL NUMBER MPU-20662, WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MPU WAS SHIPPED TO THE CUSTOMER ON 12OCT2015. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOBILE POWER UNIT'S PATIENT CABLE RUBBER CASING WAS COMING LOOSE. THE RED BATTERY STRAP WAS DAMAGED AND THE HANDLE WAS SLIGHTLY CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776055 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107758

    Patients

    Seq Age Sex Outcome Treatment
    1