BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT SIII

    MDR report key: 1243763 · Received November 18, 2008

    Report

    Report Number
    1243763
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    October 3, 2008
    Report Date
    November 18, 2008
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE RE-WARMING PHASE POST CROSS-CLAMP REMOVAL OF OPEN HEART SURGERY, THE CARDIOPULMONARY BYPASS SUPPORT WAS INTERRUPTED BY A PUMP FAILURE. THE PATIENT HAD BEEN COOLED TO 26 DEGREES CENTIGRADE (RECTAL). PERFUSIONIST IMMEDIATELY BEGAN HAND-CRANKING THE MACHINE TO MAINTAIN BYPASS SUPPORT. PERFUSIONIST WAS UNABLE TO RE-ESTABLISH PUMP FLOW. POWER TURNED OFF TO PUMP, CLAMP APPLIED TO THE ARTERIAL LINE TO THE PATIENT, AND THEN PUMP POWERED UP AGAIN. PUMP WORKED AS NORMAL AT THIS POINT. CARDIOPULMONARY BYPASS WAS RE-ESTABLISHED TO THE PATIENT AFTER APPROPRIATE MEASURES WERE TAKEN BY THE PERFUSIONIST TO MAKE THE LINES SAFE FOR THE PERFUSION. NO APPARENT SEQUELA TO THE PATIENT ALTHOUGH THE PATIENT WAS WITHOUT AN APPRECIABLE BLOOD PRESSURE FOR APPROXIMATELY 2 MINUTES.====================== MANUFACTURER RESPONSE FOR PUMP, CARDIOPULMONARY, STOCKERT SIII ======================BIOMED SPECIALIST CONTACTED THE MANUFACTURER. THE REPRESENTATIVE WAS UNAWARE OF SIMILAR ISSUES WITH THIS TYPE OF PUMP. SUGGESTED MAKING SURE PRESSURE TRANSDUCERS WERE NOT OVERUSED (CONFIRMED NOT A PROBLEM IN THIS CASE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT SIII PUMP, CARDIOPULMONARY DWB COBE CARDIOVASCULAR, INC. SIII *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DAY