BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9970410 · Received April 16, 2020

    Report

    Report Number
    2916596-2020-02147
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    April 13, 2020
    Report Date
    June 9, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q419-MCS-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MPU NOT POWERING ON WAS CONFIRMED. THE MPU WAS TESTED ON 20MAY20. THE POWER SUPPLY PCB WAS REPLACED WHICH RESOLVED THE ISSUE. THE UNIT REQUIRED PREVENTATIVE MAINTENANCE. A FULL FUNCTIONAL CHECKOUT WAS PERFORMED AND THE UNIT PASSED ALL TESTS. IT WAS RETURNED TO THE CUSTOMER SITE. THE MPU POWER SUPPLY PCB WAS FORWARDED TO PPE FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED MPU POWER SUPPLY PCB REVEALED NO DAMAGE TO ANY COMPONENTS. THE EVALUATION OF THE SECONDARY SIDE OF THE POWER SUPPLY REVEALED A SHORTED Q2 MOSFET AND D26 DIODE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE DAMAGED POWER SUPPLY PCB COMPONENTS; HOWEVER THE ROOT CAUSE FOR THE DAMAGE WAS NOT DETERMINED. 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 III PATIENT HANDBOOK AND HEARTMATE III INSTRUCTIONS FOR USE (IFU) SECTION 3 ¿POWERING THE SYSTEM¿ EXPLAIN HOW TO USE ALL SYSTEM CONTROLLER POWER SOURCES, INCLUDING THE MPU. THIS SECTION STATES ¿IF THERE IS A POWER FAILURE, TRANSFER FROM THE MOBILE POWER UNIT TO ANOTHER POWER SOURCE. THE BACKUP BATTERY IN THE SYSTEM CONTROLLER WILL TEMPORARILY POWER THE PUMP WHILE TRANSFERRING TO BATTERY POWER. DO NOT RELY ON THE SYSTEM CONTROLLER¿S BACKUP BATTERY AS A POWER SOURCE DURING AC POWER FAILURE, AS IT WILL ONLY POWER THE PUMP FOR A LIMITED AMOUNT OF TIME AND THE PUMP WILL STOP¿. THIS SECTION INFORMS THE USER OF THE PROPER ACTIONS TO TAKE IF THE GREEN POWER ON LIGHT DOES NOT ILLUMINATE WHEN THE MPU IS PLUGGED IN. THIS SECTION ALSO INFORMS THE USER TO INSPECT THE MPU PATIENT CABLE AND AC POWER CABLE FOR DAMAGE DAILY, AND NOT TO USE THE MPU IF EITHER CABLE SHOWS SIGNS OF DAMAGE. HEARTMATE III PATIENT HANDBOOK SECTION 6 ¿CARING FOR THE EQUIPMENT¿ AND HEARTMATE III INSTRUCTIONS FOR USE (IFU) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ EXPLAIN HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE MPU. HEARTMATE III PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ AND HEARTMATE III INSTRUCTIONS FOR USE (IFU) SECTION E ¿SAFETY CHECKLISTS¿ PROVIDE THE USER WITH CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF ALL COMPONENTS OF THE HEARTMATE III LEFT VENTRICULAR ASSIST DEVICE, INCLUDING THE MPU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MALFUNCTION ON THEIR MPU. THE PATIENT EXPERIENCED A LOSS OF EXTERNAL POWER WHILE ON THE MPU. THE PATIENT SWITCHED TO BATTERY POWER SUCCESSFULLY. THE MPU WOULD NOT TURN ON. THE PATIENT WAS GIVEN A LOANER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429874 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR