BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN HEART PARK W/HMO 7

    MDR report key: 4210855 · Received August 1, 2014

    Report

    Report Number
    2248146-2014-00333
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OXYGENATOR LEAK. THE RETURNED DEVICES WERE RETURNED AND FORWARDED TO (B)(4) FOR EVALUATION AS THEY WERE NOT MANUFACTURED AT OUR FACILITY. THE QUALITY ENGINEER TESTED THE OXYGENATOR ON TIGHTNESS IN THE LABORATORY. THE QUALITY ENGINEER FILLED IT BLOOD SIDE WITH WATER AND IMMEDIATELY FOUND A LEAKAGE ON THE BLOOD SIDE. THE QUALITY ENGINEER OPENED THE OXYGENATOR TO FIND THE REASON. AS A RESULT, THE QUALITY ENGINEER OBSERVED AN ABLATION OF THE POLYURETHANE. THE ENDS OF THE GAS FIBERS WERE EMBEDDED IN POLYURETHANE. THERE WAS A LEAK IN A POLYURETHANE ADHESION. THE REASON FOR THIS FAILURE IS STILL UNKNOWN. EACH OXYGENATOR IS TESTED FOR TIGHTNESS DURING THE PRODUCTION PROCESS. THE TEST OF THE BLOOD SIDE TIGHTNESS WAS CARRIED OUT AT 1 BAR (- 14 PSI) FOR A TIME PERIOD OF 75 MIN AT A FLOW OF 10 1/MIN. DURING THIS TEST THE OXYGENATORS ARE CHECKED FOR ANY LEAKS. THE QUALITY ENGINEER CHECKED THE PRODUCTION RECORDS OF THE COMPLAINED OXYGENATOR BUT COULD NOT FIND ANY DEVIATIONS. USUALLY, LEAKS ARE DETECTED DURING THIS TEST. HOWEVER, IN THE REPORTED CASE NOTHING ABNORMAL WAS FOUND DURING PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    AN OXYGENATOR WAS LEAKING OUT OF THE BOTTOM OF THE EXHAUST PORT. PRIME WAS LEAKING A CONTINUOUS STREAM OUT OF THE BOTTOM. VIDEO INCLUDED WITH REPORT. PERFUSIONIST TOOK OFF THE OXYGENATOR AND RESERVOIR AND REPLACED IT WITH ANOTHER PACK. NO INJURIES REPORTED. PRODUCT INDICATED AS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451944 OPEN HEART PARK W/HMO 7 CARDIOPULMONARY DEVICE DTZ DATASCOPE CORP. BEQ-TOP 4903 12973

    Patients

    Seq Age Sex Outcome Treatment
    1