BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 4951538 · Received July 28, 2015

    Report

    Report Number
    2248146-2015-00063
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    DATASCOPE CORP
    Product Code
    DTL
    PMA / PMN Number
    K080592
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND WAS EVALUATED. THIS COMPLAINT WAS INVESTIGATED IN THE GERMAN NON-CONFORMANCE SYSTEM. THE INVESTIGATION SHOWED A FIBER DELAMINATION. THE FAILURE MODE IS KNOWN AND COVERED IN CAPA (B)(4). INTERNAL COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MAQUET ECLS (EXTRA CORPOREAL LIFE SUPPORT) PACK WAS USED TO PLACE A PATIENT ON ECLS. THE CIRCUIT WAS PRIMED WELL AND PATIENT WAS PLACED ON ECLS WITHOUT DIFFICULTY. AFTER SEVERAL MINUTES THE QUADROX OXYGENATOR BEGAN TO LEAK BLOOD IN SMALL AMOUNTS FROM THE VENT. THE PATIENT WAS NOT EXPERIENCING ANY REDUCTION IN OXYGENATION STATUS SO THE PHYSICIAN DECIDED TO CUT OUT THE LEAKING OXYGENATOR AND REPLACE WITH A NEW QUADROX OXYGENATOR. THIS WAS DONE WITHOUT EVENT AND THE PATIENT WAS SUPPORTED APPROPRIATELY. THE LEAKING QUADROX WAS SAVED TO BE RETURNED TO MAQUET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490693 CUSTOM TUBING PACK CARDIOPULMONARY DTL DATASCOPE CORP BEQ-01970311 3000009934

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other