BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 3060652 · Received April 5, 2013

    Report

    Report Number
    1828100-2013-00376
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE FUSE AND HOLDER CAP. WITH THESE PARTS REPLACED, THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE DELPHIN BATTERY WAS MISSING A FUSE AND FUSE CAP. THIS ISSUE RESULTED IN THE BATTERY MODULE NOT BEING ABLE TO POWER THE DELPHIN CONTROL MODULE. PER FSR, THE WEDGE AND DELPHI BATTERY WERE NOT BEING USED AND WERE ON THE SHELF. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141731 TERUMO CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEM CORP 9490

    Patients

    Seq Age Sex Outcome Treatment
    1