BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE®, MOBILE POWER UNIT, N/A

    MDR report key: 19747361 · Received July 15, 2024

    Report

    Report Number
    2916596-2024-04618
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 24, 2024
    Report Date
    October 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067038234
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G3: IT IS UNKNOWN WHICH DEVICE THE PATIENT WAS IMPLANTED WITH AT THE TIME OF THE EVENT. THE PMA# PROVIDED IS ASSOCIATED WITH MOST RECENT APPROVAL. 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 THE MOBILE POWER UNIT (MPU) ALARMING WAS CONFIRMED. THE MPU (SERIAL NUMBER: (B)(6) WAS RETURNED FOR ANALYSIS TO THE SERVICE DEPOT AND WAS CONNECTED TO AC POWER AND BOOTED UP AS EXPECTED. A TEST SYSTEM CONTROLLER WAS CONNECTED TO THE MPU, AND THE UNIT SUPPLIED POWER AS INTENDED; HOWEVER, UPON CONNECTION OF THE DRIVELINE TO THE SYSTEM CONTROLLER, A CONNECT POWER ALARM ON BOTH CABLES BECAME ACTIVE. A TEST PATIENT CABLE WAS INSERTED INTO THE MPU, AND THE UNIT FUNCTIONED AS INTENDED WITHOUT ANY ALARMS OCCURRING. NO FURTHER TESTING WAS PERFORMED. THE MPU WAS AUTHORIZED TO BE SCRAPPED AND WAS SENT TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. THE MPU WAS CONNECTED TO A TEST SYSTEM CONTROLLER, AND MOCK LOOP DURING TESTING WITH PPE. THE SYSTEM WAS RUN FOR AN EXTENDED DURATION WITHOUT ANY ALARMS OR ISSUES ACTIVATING. MANIPULATION OF THE CABLE DID NOT CAUSE ANY ALARMS TO ACTIVATE. THE MPU WAS THEN OPENED, AND THE INSULATION AND RESISTANCE OF THE PATIENT CABLE WERE MEASURED. ALL UNDERLYING WIRES WITHIN THE CABLE MEASURED AS EXPECTED. NO ISSUES WERE OBSERVED DURING TESTING WITHIN PPE. A ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED, AND THE RECORDS REVEALED THE MOBILE POWER UNIT (SERIAL NUMBER: (B)(6) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. CUSTOMER ORDER WAS SHIPPED ON 19APR2023. 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. ADDITIONALLY, HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ENTITLED ¿SAFETY CHECKLISTS¿, INSTRUCTS USERS TO REGULARLY INSPECT THEIR ACCESSORIES FOR DAMAGE, AND TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 3 ¿ ¿POWERING THE SYSTEM¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 3 ¿ ¿POWERING THE SYSTEM¿ ADDRESSES THE USER TO NOT USE EXPIRED BATTERIES AND ADVISES THE USER TO PROPERLY DISPOSE OF THEM. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO TROUBLESHOOT THE SYSTEM CONTROLLER, INCLUDING NO EXTERNAL POWER, LOW VOLTAGE AND POWER CABLE DISCONNECT ALARMS. HEARTMATE 3 PATIENT HANDBOOK AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) CAUTION 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 PATIENT HAD CONNECTED THEIR MOBILE POWER UNIT (MPU) AT HOME AND THE SYSTEM CONTROLLER HAD A LOW VOLTAGE ALARM. THE PATIENT CALLED THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR TO TROUBLESHOOT AND WAS CONNECTED CORRECTLY TO THE MPU. THE PATIENT BROUGHT THE MPU TO THE CLINIC FOR ASSESSMENT. THERE WERE NO OVERT SIGNS OF DAMAGE NOTED. THEY ASSESSED ALL CONNECTIONS AND WATCHED THE PATIENT CONNECT TO THE MPU TO ENSURE WHITE TO WHITE AND BLACK TO BLACK CONNECTORS WERE MADE CORRECTLY. THEY ASSESSED ALL PINS AND DID NOT SEE ANY BENT PINS INSIDE THE CONNECTORS. MPU PASSED THE SELF-TEST WHEN PLUGGED INTO THE WALL. THE PATIENT CONNECTED TO THE MPU AND EXPERIENCED LOW VOLTAGE ALARMS AGAIN IN CLINIC. A NEW MPU WAS ISSUED AND THE PATIENT CONNECTION THE SAME SYSTEM CONTROLLER TO THE NEW MPU IN CLINIC AND NO ALARMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504661 HEARTMATE®, MOBILE POWER UNIT, N/A VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107758AU 8975367 05415067038234

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male