BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 2960711 · Received January 25, 2013

    Report

    Report Number
    1828100-2013-00058
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K890024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-CARDIOPULMONARY BYPASS OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE BLUE STOPPER OF THE AORTIC CANNULA WAS LEAKING OUT INSTEAD OF PREVENTING THE BLOOD FROM COMING OUT. THE USER PLACED A CLAMP ON THE END SO THAT THE BLOOD COULD NOT FLOW OUT UNTIL THEY COULD CONNECT TO THE TUBING FOR THE CIRCUIT. AROUND 100CCS OF BLOOD ESCAPED, HOWEVER, THE SURGEON WAS ABLE TO USE THE SUCKER PUMP TO REINCORPORATE THE BLOOD THAT LEAKED BACK INTO THE CIRCUIT SO THAT THERE WAS NO BLOOD LOSS. THE DEVICE WAS NOT CHANGE OUT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO DELAYS, NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35948 CATHETER AND CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 4948 0691202

    Patients

    Seq Age Sex Outcome Treatment
    1