BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 10402384 · Received August 13, 2020

    Report

    Report Number
    2916596-2020-04083
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 2, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024010890
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THERE WAS AN INCIDENTAL FINDING OF DAMAGE TO THE MPU PATIENT CABLE. THE REPORTED EVENT OF DAMAGE TO THE MOBILE POWER UNIT (MPU) HOUSING WAS CONFIRMED. THE MPU WAS RETURNED TO THE EUROPEAN DISTRIBUTION CENTER (EDC) AND EVALUATED. VISUAL INSPECTION OF THE RETURNED MPU REVEALED A DENT IN THE MPU HANDLE AND A CRACK IN THE MPU BATTERY DOOR. INSPECTION ALSO REVEALED SMALL DENTS ON THE TOP HOUSING AND ONE OF THE MPU¿S RUBBER FEET WAS OBSERVED TO BE MISSING. THE RETURNED MPU FUNCTIONED AS INTENDED DURING ANALYSIS AND NO ATYPICAL ALARMS WERE PRODUCED. THE MPU HANDLE AND THE TOP AND BOTTOM HOUSING WERE PLACED DUE TO THE OBSERVED DAMAGE. THE MPU WAS THEN FUNCTIONALLY TESTED AND THE UNIT PASSED ALL TESTS WITHOUT ANY ISSUES. 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) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE MPU WAS SHIPPED TO THE CUSTOMER ON 06MAY2016. 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 AND THE 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 · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THERE WAS AN INCIDENTAL FINDING OF DAMAGE TO THE MPU PATIENT CABLE. THE REPORTED EVENT OF DAMAGE TO THE MOBILE POWER UNIT (MPU) HOUSING WAS CONFIRMED. THE MPU WAS RETURNED TO THE EUROPEAN DISTRIBUTION CENTER (EDC) AND EVALUATED. VISUAL INSPECTION OF THE RETURNED MPU REVEALED A DENT IN THE MPU HANDLE AND A CRACK IN THE MPU BATTERY DOOR. INSPECTION ALSO REVEALED SMALL DENTS ON THE TOP HOUSING AND ONE OF THE MPU¿S RUBBER FEET WAS OBSERVED TO BE MISSING. THE RETURNED MPU FUNCTIONED AS INTENDED DURING ANALYSIS AND NO ATYPICAL ALARMS WERE PRODUCED. THE MPU HANDLE AND THE TOP AND BOTTOM HOUSING WERE PLACED DUE TO THE OBSERVED DAMAGE. THE MPU WAS THEN FUNCTIONALLY TESTED AND THE UNIT PASSED ALL TESTS WITHOUT ANY ISSUES. 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) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE MPU WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2016. 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 DEVICE CAME BACK FOR ROUTINE MAINTENANCE AND THE TECHNICIAN RECOGNIZED THAT THE HOUSING WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866139 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION L107758 173586 813024010890

    Patients

    Seq Age Sex Outcome Treatment
    1