BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MADIGAN ARMY TACOMA WA 1

    MDR report key: 1560157 · Received December 7, 2009

    Report

    Report Number
    1718850-2009-00096
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 2, 2009
    Report Date
    November 6, 2009
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRIMO2X IS A COMPONENT OF THE CUSTOM PERFUSION PACK (B) (4). THE PACK IS A PREAMENDMENT DEVICE. THE PRIMO2X 510(K) NUMBER IS K050447. THE CLINICIAN REPORTED THAT UPON INITIATION OF BYPASS, THE VENOUS RETURN APPEARED TO BE RESTRICTED. BLOOD WAS GIVEN TO MAINTAIN VOLUME. IT WAS REPORTED THAT THE PATIENT LATER EXPIRED DUE TO AN UNRELATED ISSUE. THE PERFUSIONIST DISCARDED THE DEVICE IN QUESTION. HOWEVER, ONE UN-USED PRIMO2X OXYGENATOR FROM THE SAME LOT WAS RETURNED FOR EVALUATION. LABORATORY TESTING COULD NOT DUPLICATE THE VENOUS RESISTANCE AS DESCRIBED BY THE PERFUSIONIST. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. THE DEVICE IN QUESTION IS NOT AVAILABLE FOR TESTING. NO FURTHER EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT UPON INITIATION OF BYPASS, THE VENOUS RETURN APPEARED TO BE RESTRICTED. BLOOD WAS GIVEN TO MAINTAIN VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MADIGAN ARMY TACOMA WA 1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 0919400097

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR