BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX25 OXYGENATOR

    MDR report key: 1081054 · Received July 21, 2008

    Report

    Report Number
    1124841-2008-00021
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS DECONTAMINATED, VISUALLY EXAMINED AND FUNCTIONALLY TESTED FOR RECIRCULATION AND FOR CR FILTER BREAKTHROUGH TIME. THE RESERVOIR WAS CONFIRMED TO FUNCTION PROPERLY AND NO ABNORMALITIES WERE NOTED DURING ANY OF THE TESTING. THE BREAKTHROUGH TIME WAS FOUND TO BE CONSISTENT WITH PERFORMANCE DATA FOR THIS DEVICE. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS PRODUCT CODE/LOT NUMBER. THERE ARE MANY COMPLEX CLINICAL VARIABLES THAT MAY HAVE AFFECTED THE REPORTED CONCERN OF FLOW RESTRICTION. HOWEVER, THERE IS NO AVAILABLE EVIDENCE THAT THE REPORTED EVENT WAS RELATED TO A PRODUCT MALFUNCTION OR DEFECT. CIRCUIT FLOW PERFORMANCE UNDER STANDARDIZED CONDITIONS IS ADDRESSED IN THE DEVICE LABELING. ALL AVAILABLE INFO HAS BEEN MAINTAINED IN THE QUALITY ASSURANCE FILES FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE CARDIOTOMY FILTER WOULD NOT ALLOW PASSAGE OF FLUID REQUIRING A CHANGE OUT DURING A BYPASS PROCEDURE. FOLLOW-UP INFO WITH THE USER FACILITY CONFIRMED THAT THEY PRIMED THE SYSTEM RECIRCULATING THE PRIME THROUGH THE CARDIOTOMY RESERVOIR SO THE FILTRATION MEDIA WAS WETTED. A UNIT OF BANKED RED CELLS WAS DEEMED NECESSARY AND ADDED TO THE CARDIOTOMY SIDE OF THE VENOUS RESERVOIR. THE BLOOD WAS FIRST PASSED THROUGH A PALL SQ-40S BLOOD FILTER BEFORE ENTERING THE RESERVOIR. THE UNIT OF BLOOD HAD 5,000 UNITS OF HEPARIN ADDED TO IT PRIOR TO ADMINISTRATION. IMMEDIATELY IT WAS NOTED THAT THE BLOOD WAS HELD UP IN THE CARDIOTOMY FILTER MEDIAL WITH ESSENTIALLY NO BREAK THROUGH AT ALL. THE PERFUSIONIST THEN ADDED PLASMALYTE THROUGH THE RAPID PRIME LINE AND THAT VOLUME WAS HELD UP AS WELL. THE DECISION WAS MADE TO CHANGE OUT THE RESERVOIR AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX25 OXYGENATOR OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA KD24

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PALL FILTER