BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 4363790 · Received December 18, 2014

    Report

    Report Number
    1828100-2014-01111
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CCP REPLACED THE ENTIRE DEVICE WITH A SPARE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THE CENTRIFUGAL MOTOR RUBBED UP AGAINST SOMETHING AND THE WHITE, SPRING-LOADED CLIP THAT HOLDS THE CENTRIFUGAL PUMP IN PLACE CRACK/BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835387 TERUMO CENTRIFUGAL SYSTEM SARNS CENTRIFUGAL SYSTEM DWA TERUMO CARDIOVASCULAR SYSTEM CORP 164267

    Patients

    Seq Age Sex Outcome Treatment
    1