BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3871602 · Received April 16, 2014

    Report

    Report Number
    1828100-2014-00264
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER FIELD SERVICE REPRESENTATIVE (FSR), HE ALLOWED SYSTEM TO CHARGE FOR TWO HOURS WHILE COMPLETING THE REMAINDER OF THE PM; CAPACITY NOW AT 17AH. THE FSR TRIED A/C DISCONNECT TEST AND UNIT WOULD NOT STAY POWERED UP ON BATTERY POWER. THE FSR DISCUSSED ISSUE WITH CUSTOMER. THEY STATED THEY HAVEN'T USED THE SYSTEM IN OVER A YEAR AND DO NOT HAVE ANY DISPOSABLE ITEMS TO USE WITH THE SYSTEM AND PROBABLY WILL NOT EVER USE IT AGAIN. THE CUSTOMER WILL ADVISE THE FSR WHETHER OR NOT THEY WILL REPLACE THE BATTERIES OR TO SIMPLY RETIRE THE SYSTEM. THE PERFUSION SYSTEM MET ALL OTHER MANUFACTURER SPECIFICATION FOR OPERATION, AND THE FSR DID NOT ATTACH AN INSPECTION STICKER.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, FOUND PERFUSION SYSTEM BATTERY CAPACITY AT 13AH. THIS SYSTEM HAD NOT BEEN POWERED ON SINCE (B)(6) 2013. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233612 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1