BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BULK NON STER XCOAT DELPH PUMP

    MDR report key: 5151459 · Received October 15, 2015

    Report

    Report Number
    1124841-2015-00278
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 24, 2015
    Report Date
    October 23, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    KFM
    PMA / PMN Number
    K112229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS VISUALLY INSPECTED UPON RECEIPT, DURING WHICH IT WAS NOTED THAT THERE WAS A BLACK MARK ON THE SEPARATOR WHERE THE LEAK OCCURRED AND THERE WERE CRACKS ALONG THE BOTTOM OF THE TOP HOUSING, NOT NEAR THE BLACK MARK. THE CRACKS WERE IN THE TOP HOUSING LOCATED AT THE TOP HOUSING / SEPARATOR WELD OPPOSITE OF THE OUTLET PORT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THE SAMPLE WAS THEN SET UP ON A SARNS DRIVE MOTOR BUILT INTO A CIRCUIT OF SALINE SOLUTION. THE RPM WAS SET TO 3500 RPM WITH A BACK PRESSURE OF 660 MMHG AND RAN FOR TWO HOURS. THE PUMP DID NOT LEAK. A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/LOT COMBINATION AS THE ACTUAL SAMPLE WAS OBTAINED FOR TEST EVALUATION. THE RETENTION SAMPLE WAS INSPECTED AND THERE WERE NO ANOMALIES NOTED ON THE DEVICE. ALTHOUGH THE EVENT COULD NOT BE DUPLICATED DURING THE INVESTIGATION, THE EVENT WAS CONFIRMED. THE EXTERNAL LEAK WAS MOST LIKELY DUE TO THE CRACKS IN THE TOP HOUSING LOCATED AT THE TOP HOUSING / SEPARATOR WELD. ALL CENTRIFUGAL PUMPS ARE SUBJECT TO A 100% LEAK TEST PRIOR TO PACKAGING. BECAUSE THE PUMP WAS MANUFACTURED TO SPECIFICATIONS AND PASSED A 20.5 PSI POSITIVE PRESSURE LEAK TEST DURING PRODUCTION, THE POTENTIAL CAUSE OF THE CRACK DEVELOPED POST PROCESSING IS DUE TO SHIPPING OR HANDLING. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4). CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT DURING CARDIOPULMONARY BYPASS THE CENTRIFUGAL PUMP LEAKED FROM THE BOTTOM OF THE DEVICE. DURING THE CASE, THE PUMP WAS PUSHED APPROXIMATELY 4 INCHES FORWARD TO ACCOMMODATE TIGHT LINES WHEN IT WAS NOTICED THAT THERE WAS A SPOT OF BLOOD ABOUT THE SIZE OF A QUARTER UNDER THE PUMP. UPON INVESTIGATING, IT WAS DISCOVERED THAT THE BLOOD CAME FROM THE CENTRIFUGAL PUMP HEAD. THE LOCATION OF THE LEAK WAS DRIED, AND DID NOT LEAK AFTER THIS. THIS OCCURRED DURING THE MIDDLE OF THE CASE WHEN THE TEMPERATURE WAS ROUGHLY 33-34 DEGREES CELSIUS. BLOOD LEAK OF APPROXIMATELY 1 - 2CC. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685004 BULK NON STER XCOAT DELPH PUMP CENTRIFUGAL PUMP KFM TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ164275X TE29

    Patients

    Seq Age Sex Outcome Treatment
    1