BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE®, MOBILE POWER UNIT, N/A

    MDR report key: 13501652 · Received February 9, 2022

    Report

    Report Number
    2916596-2022-00468
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 18, 2022
    Report Date
    December 6, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT (MPU) NOT FUNCTIONING WAS ABLE TO BE CONFIRMED. THE MPU (SERIAL NUMBER: (B)(6) ) WAS RETURNED FOR ANALYSIS TO THE SERVICE DEPOT AND WAS EVALUATED AND TESTED. THE MPU WAS RETURNED DUE TO THE MPU NOT TURNING ON. THE MPU WAS VISUALLY INSPECTED AND THE POWER SUPPLY PCB WAS FOUND TO BE DAMAGED. THE POWER SUPPLY PCB WAS REPLACED AND THE MPU WAS ABLE TO OPERATE AS INTENDED FOLLOWING THE REPAIR. THE MPU WAS RETURNED TO THE CUSTOMER AND THE POWER SUPPLY PCB WAS SENT TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER EVALUATION. UNDER FURTHER INVESTIGATION WITH PPE, THE SOLDERING ON THE FUSE (F1) WAS FOUND TO BE DAMAGED AND THE FUSE WAS FOUND TO BE OPENED AND NOT CONNECTED TO THE PCB. THE FUSE WAS REMOVED TO INSPECT THE DAMAGED THROUGH-HOLE. THE FUSE WAS REPLACED AND THE PCB WAS INSERTED INTO A TEST MPU. WHEN THE MPU WAS CONNECTED TO POWER, THE NEW FUSE IMMEDIATELY OPENED AND THE MPU DID NOT TURN ON. THE PCB UNDERWENT CIRCUIT ANALYSIS MULTIPLE COMPONENTS WERE FOUND TO BE SHORTED TO GROUND. THE PCB WAS DETERMINED TO BE TOO DAMAGED TO REPAIR AND NO FURTHER TESTING WAS CONDUCTED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MPU (SERIAL NUMBER: (B)(6) ) AND WAS FOUND TO PASS ALL MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. 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

    SECTION D1 - BRAND NAME: CORRECTED SECTION D4 - CATALOG NUMBER: CORRECTED SECTION D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER: CORRECTED SECTION H3 - DEVICE EVALUATED BY MANUFACTURER: CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: UNDER FURTHER INVESTIGATION WITH PPE, THE FUSE (F1) WAS FOUND TO BE ELECTRICALLY OPENED. THE PCB UNDERWENT CIRCUIT ANALYSIS AND THE DIODE D1 AND THE MOSFET Q1 WERE FOUND TO BE SHORTED TO GROUND. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MPU (SERIAL NUMBER: (B)(6)) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER ON 27OCT2021. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BROUGHT THEIR MOBILE POWER UNIT (MPU) TO THE CLINIC ON (B)(6) 2022 FOR ASSESSMENT. THE MPU WOULD NOT TURN ON WHEN PLUGGED INTO AN AC OUTLET. THE MPU WAS ASSESSED AND WAS NOT WORKING AS THE PATIENT HAD REPORTED. THE MPU WAS PLUGGED INTO MULTIPLE DIFFERENT OUTLETS BUT STILL DID NOT TURN ON. THE CLINIC PROVIDED THE PATIENT WITH A LOANER MPU AND THE MALFUNCTIONING MPU WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297222 HEARTMATE®, MOBILE POWER UNIT, N/A VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male