BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, EU

    MDR report key: 13053812 · Received December 21, 2021

    Report

    Report Number
    2916596-2021-07516
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 24, 2021
    Report Date
    February 21, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MOBILE POWER UNIT (MPU) NOT TURNING ON AND NOT BEING ABLE TO SUPPORT THE PATIENT WAS CONFIRMED VIA ANALYSIS OF THE RETURNED UNIT. THE HEARTMATE MOBILE POWER UNIT (SERIAL NUMBER (B)(6) WAS RETURNED AND EVALUATED AT THE EUROPEAN DISTRIBUTION CENTER ON 17DEC2021. THE MPU WAS CONNECTED TO POWER AND THE SYSTEM DID NOT LIGHT UP AS INTENDED, CONFIRMING THE REPORTED EVENT. THE ISSUE WAS THEN ISOLATED TO THE POWER SUPPLY PRINTED CIRCUIT BOARD (PCB) AND THE POWER SUPPLY PCB WAS FORWARDED TO PRODUCT PERFORMANCE ENGINEERING FOR FURTHER ANALYSIS. THE MPU WAS FURTHER EVALUATED BY PPE. PPE EVALUATION OF THE RETURNED MPU POWER SUPPLY PCB REVEALED THAT SEVERAL COMPONENTS ON THE PCB WERE ELECTRICALLY COMPROMISED. DAMAGE TO THESE COMPONENTS WOULD PREVENT THE UNIT FROM POWERING ON AND PROVIDING POWER TO THE SYSTEM CONTROLLER. PROVIDED INFORMATION STATED THAT THE MOBILE POWER UNIT (MPU) WILL BE RETURNING. THERE WAS NO EXTERNAL POWER ON THE MPU WHILE THE MPU WAS PLUGGED, THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD, THE MPU WAS PLUGGED IN DURING THE EVENT, AND THERE WERE NO ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT. THE REPORTED EVENT WAS DETERMINED TO BE CAUSED BY DAMAGE TO THE COMPONENTS ON THE MPU POWER SUPPLY PCB; HOWEVER, THE ROOT CAUSE OF THE DAMAGE TO THESE COMPONENTS COULD NOT BE DETERMINED. INCIDENTAL FINDINGS: CORROSION ON THE BATTERY HOLDER TERMINAL THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE MOBILE POWER UNIT (SERIAL#: (B)(6) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 3 ¿ ¿POWERING THE SYSTEM¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 3 ¿ ¿POWERING THE SYSTEM¿ EXPLAINS HOW TO PROPERLY USE THE MOBILE POWER UNIT (MPU) AND THAT IN THE EVENT THE MPU LOSES POWER THE PATIENT IS INSTRUCTED TO SWITCH POWER SOURCES AS THE BACKUP BATTERY IN THE SYSTEM CONTROLLER WILL ONLY TEMPORARILY POWER THE PUMP. THIS SECTION ALSO INSTRUCTS THE USER ON THE ACTIONS TO TAKE IF THE GREEN POWER ON LIGHT DOES NOT ILLUMINATE WHEN THE MPU IS PLUGGED INTO A POWER SOURCE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ¿ ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ¿ ¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. ADDITIONALLY, SECTION 10 OF THE PATIENT HANDBOOK ENTITLED ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF THE HEARTMATE 3 LVAD, INCLUDING THE MPU. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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 DURING PATIENT TRAINING THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR WAS NOT ABLE TO SUPPORT THE PATIENT WITH THE MOBILE POWER UNIT (MPU). THE MPU DISPLAYED POWER CABLE DISCONNECTED ALARM. THE MPU HAD A V-LOCK CONNECTOR ON THE AC POWER CORD. THE MPU WAS PLUGGED IN WELL TO THE WALL/OUTLET. THERE WERE NO ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED AC POWER AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954574 HEARTMATE MOBILE POWER UNIT, EU VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107758 6575050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown