BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CENTRIFUGAL SYSTEM

    MDR report key: 2040575 · Received March 18, 2011

    Report

    Report Number
    1828100-2011-00698
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 7, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWA
    PMA / PMN Number
    K950739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE PUMP DISPLAYED AN OVERSPEED ALARM. THE PUMP SHUT DOWN AS A RESULT, CREATING A NO FLOW INCIDENT. THE PUMP WAS RESTARTED, BUT AGAIN IN A FEW SECONDS AN OVERSPEED ALARM CAUSED THE ARTERIAL PUMP TO STOP. THE USER HAND CRANKED THE PUMP WHILE A BACK-UP MOTOR WAS RETRIEVED AND CONNECTED TO THE SYSTEM 1. HAND CRANKING LASTED ABOUT 3 MINUTES. THE BACK-UP MOTOR WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE CASE WAS DELAYED ABOUT 2 MINUTES. THERE WAS NO BLOOD LOSS AND NO NEED FOR TRANSFUSION. THE USER REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CENTRIFUGAL SYSTEM CENTRIFUGAL CONTROL MODULE DWA TERUMO CARDIOVASCULAR SYSTEMS CORP. 164267

    Patients

    Seq Age Sex Outcome Treatment
    1