BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE®, MOBILE POWER UNIT, N/A

    MDR report key: 20076664 · Received August 27, 2024

    Report

    Report Number
    2916596-2024-05438
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 5, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE LOT NUMBER WAS NOT PROVIDED, AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS 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 AN INTERMITTENT ATYPICAL ALARM WAS UNABLE TO BE CONFIRMED. THE MPU (SERIAL NUMBER: (B)(6)) WAS RETURNED FOR ANALYSIS AND WAS EVALUATED AND TESTED ON 13SEP2024. THE MPU WAS POWERED ON AND BOOTED UP AS INTENDED. THE UNIT WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING. IT WAS STATED THE CUSTOMER AUTHORIZED TO SCRAP THE MPU AFTER ANALYSIS, AND THE MPU WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. UPON TESTING BY PPE, THE MPU WAS FOUND TO FUNCTION AS INTENDED. NO FURTHER TROUBLESHOOTING WAS PERFORMED. ATYPICAL ALARMS COMING FROM THE MPU WERE NOT REPRODUCED. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE SENT TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE AVAILABILITY OF LOG FILES, THE SOFTWARE VERSION OF THE SYSTEM CONTROLLER, IF THE MPU HAD THE V-LOCK CONNECTOR, THE CAUSE OF THE ALARMS, AND IF EXCHANGING THE MPU RESOLVED THE ALARMS; HOWEVER, NO RESPONSE WAS RECEIVED. DAMAGED HOUSING, MISSING BATTERY STRAP, AND DAMAGE TO JACKET OF PATIENT CABLE WERE ALSO NOTED DURING THE INVESTIGATION. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MOBILE POWER UNIT (SERIAL NUMBER: (B)(6)) AND IT WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE 3 PATIENT HANDBOOK SECTION 5, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, AND HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7, ENTITLED ¿ALARMS AND TROUBLESHOOTING¿, COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE NO EXTERNAL POWER CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿CARING FOR THE EQUIPMENT¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ EXPLAIN HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR NOTED THAT THE PATIENT HAD A NO EXTERNAL POWER ALARM ON THEIR SYSTEM CONTROLLER WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) PER AN ALARM HISTORY REVIEW. THE PATIENT WAS SEEN IN CLINIC AND THE VAD COORDINATOR PLUGGED THE MPU IN AT THE CLINIC. THE MPU HAD THE YELLOW REPLACE MPU BATTERIES SYMBOL ILLUMINATED. THE MPU ALSO HAD AUDIBLE INTERMITTENT BEEPS DESPITE BATTERIES BEING REPLACED. THE MPU WAS THEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19277 HEARTMATE®, MOBILE POWER UNIT, N/A VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male