BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9526006 · Received December 27, 2019

    Report

    Report Number
    2916596-2019-06029
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    March 21, 2019
    Report Date
    January 6, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4: ADDITIONAL INFORMATION. SECTION D10: CORRECTION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: P060040; P160054. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT (MPU) RATTLING INTERNALLY AND THE MPU ALARMING WITH THE YELLOW WRENCH AND BATTERY LIGHT ILLUMINATING WAS CONFIRMED VIA EVALUATION OF THE RETURNED MPU; THE REPORTED RATTLING AND THE REPORTED ALARMS WERE BOTH REPRODUCED DURING TESTING. THE RETURNED MPU WAS EVALUATED BY TECHNICAL SERVICES UNDER WORK ORDER (B)(4). VISUAL INSPECTION REVEALED THAT ONE OF THE INTERNAL PATIENT CABLE MOUNTING BRACKET NUTS HAD LOOSENED AND FALLEN OFF; THE NUT WAS FOUND UNDER THE MAIN PRINTED CIRCUIT BOARD (PCB) ASSEMBLY. TECHNICAL SERVICES REMOVED THE NUT FROM UNDERNEATH THE PCB AND TIGHTENED IT BACK ONTO THE PATIENT CABLE MOUNTING BRACKET, RESOLVING THE REPORTING RATTLING ISSUE. A YELLOW WRENCH AND BATTERY LIGHT ALARM WERE OBSERVED ON THE MPU WHEN CONNECTED TO POWER. TECHNICAL SERVICES REPLACED THE MAIN PCB AND THE ALARMS RESOLVED. THE MPU WAS THEN CONNECTED TO A MOCK CIRCULATORY LOOP AND ALLOWED TO RUN FOR SEVERAL DAYS WITHOUT ISSUE. A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND THE UNIT PASSED ALL TESTS. THE FAULTY PCB WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING (PPE) FOR FURTHER ANALYSIS. VISUAL INSPECTION OF THE PCB REVEALED SEVERAL BURNT COMPONENTS, INCLUDING THE MPU MAIN PROCESSOR. A WHITE RESIDUE CONSISTENT WITH FLUID INGRESS WAS ALSO OBSERVED ON THE PCB. FURTHER INSPECTION REVEALED A BAD SOLDER JOINT ON ONE OF THE PINS OF THE MPU MAIN PROCESSOR. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT INDICATE ANY ISSUES WITH THE MPU PRIOR TO SHIPPING. A MANUFACTURING ANALYSIS TASK WAS OPENED TO FURTHER INVESTIGATE THE LOOSE PATIENT CABLE MOUNTING BRACKET NUT AND BAD SOLDERING JOINT ISSUES. THE MANUFACTURING ANALYSIS TASK CONFIRMED THAT THE MPU PASSED SEVERAL INSPECTION CHECKPOINTS THAT WOULD HAVE DETECTED IF THE PCB WAS DAMAGED. IN ADDITION, THE MANUFACTURING PROCESS ENSURES THAT THE PATIENT CABLE MOUNTING BRACKET NUTS ARE INSTALLED AND TIGHTENED PROPERLY. THE RATTLING NOISE INSIDE THE UNIT WAS DETERMINED TO BE CAUSED BY THE DISLODGED NUT; HOWEVER, THE ROOT CAUSE OF THE NUT BECOMING LOOSE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE REPORTED ALARMS WERE DETERMINED TO BE CAUSED BY THE DAMAGED COMPONENTS ON THE MPU MAIN PCB. THE ROOT CAUSE OF THE COMPONENT DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS; HOWEVER, THE DISLODGED NUT COULD HAVE CAUSED A SHORT CIRCUIT THAT COULD RESULT IN THE COMPONENT DAMAGE AND REPORTED ALARMS. THE OBSERVED FLUID INGRESS AND BAD SOLDER JOINT COULD ALSO HAVE CONTRIBUTED TO THE DAMAGED COMPONENTS. HEARTMATE 3 PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING ALL MPU ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE 3 PATIENT HANDBOOK, SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES THE USER WITH CHECKLISTS TO ASSIST THE USER IN PERFORMING ROUTINE MAINTENANCE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE. THIS SECTION INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 PATIENT HANDBOOK, SECTION 1 ¿INTRODUCTION¿ STATED THAT THE ¿HEARTMATE 3 SYSTEM COMPONENTS MUST BE KEPT DRY. NEVER EXPOSE THE SYSTEM CONTROLLER, BATTERIES, OR MOBILE POWER UNIT TO WATER. IF THESE SYSTEM COMPONENTS GET WET, YOUR PUMP MAY STOP. NEVER TAKE TUB BATHS OR GO SWIMMING WHILE IMPLANTED WITH THE PUMP. THE HEARTMATE 3 SHOWER BAG MUST BE USED WHILE SHOWERING TO KEEP THE SYSTEM CONTROLLER AND BATTERIES DRY. SECTION 2 ¿HOW YOUR HEART PUMP WORKS¿ INFORMS THE USER TO ¿NEVER SUBMERGE THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL SYSTEM COMPONENTS (SUCH AS THE MOBILE POWER UNIT, BATTERIES, POWER CABLES, OR BATTERY CLIPS) IN WATER OR LIQUID. SUBMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP.¿ HEARTMATE 3 PATIENT HANDBOOK AND HEARTMATE 3 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ISSUES WITH THEIR MOBILE POWER UNIT (MPU) FOR SEVERAL WEEKS AND THAT THERE WERE YELLOW WRENCH AND BATTERY LIGHTS ILLUMINATING WITH AUDIBLE ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318544 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR