BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, UK

    MDR report key: 11865490 · Received May 21, 2021

    Report

    Report Number
    2916596-2021-02557
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 29, 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
    HK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS NOT CONFIRMED. THE SUBMITTED LOG FILE BELONGED TO HSC-033791 WHICH WAS THE CONTROLLER THE PATIENT EXCHANGED TO. THERE WAS NO LOG FILE FOR THE CONTROLLER IN QUESTION. THE MPU, SERIAL (B)(6), WAS NOT RETURNED FOR ANALYSIS AND REMAINS IN USE. THE PROVIDED INFORMATION STATED THAT EXCHANGING THEIR CONTROLLER RESOLVED THE NO EXTERNAL POWER ALARM. ADDITIONAL INFORMATION PROVIDED ON 14JUN21 STATED THAT THE POWER CORD CAME LOOSE AT THE WALL. A ROOT CAUSE FOR THE REPORTED EVENT WAS NOT CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT NO EXTERNAL POWER ALARMS. THE "PATIENT CARE MANAGEMENT" SECTION OF THE IFU INSTRUCTS THE PATIENT TO KEEP A FLASHLIGHT, FULLY-CHARGED BATTERIES, AND BATTERY CLIPS WITHIN REACH TO BE PREPARED FOR A POWER OUTAGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2021-02555 AND 2916596-2021-02556.

    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 WHEN THE PATIENT SWITCHED TO THE MPU FROM BATTERY, THE RUNNING SYMBOL WAS OFF. THERE WAS A NO EXTERNAL POWER AND LOW FLOW ALARM OCCURRED AT THE SAME TIME. THE PATIENT WAS CLINICALLY STABLE DURING THE EVENT. THE PATIENT EXCHANGED THEIR CONTROLLER AND THE ALARMS RESOLVED, EXCEPT THE LOW FLOW. THE PATIENT WAS ASYMPTOMATIC DURING THE EXCHANGE. AN ECHO WAS PERFORMED WHICH FOUND NO PUMP MALPOSITION OR OBSTRUCTION. THE LOW FLOWS HAVE CONTINUED INTERMITTENTLY. THE PLAN OF CARE WAS TO CONTINUE WITH ROUTINE CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761705 HEARTMATE MOBILE POWER UNIT, UK VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107758UK 7054860

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention