BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NE HRT HSP LINCOLN, NE1

    MDR report key: 1030450 · Received April 16, 2008

    Report

    Report Number
    1718850-2008-00007
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    K020997
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APEX OXYGENATOR MANUFACTURED BY SORIN GROUP ITALIA IS A COMPONENT IN THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA, INC. THE CUSTOM PACK, CATALOG NUMBER 084102603, IS A PRE-AMENDMENT DEVICE. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED APEX OXYGENATOR. THE VISUAL INSPECTION SHOWED NO DEFECTS. THE OXYGENATOR HEAT EXCHANGE INTEGRITY WAS EVALUATED THROUGH A PRESSURE DECAY AND WATER TO BLOOD SIDE LEAK TEST. BOTH PHYSICAL TESTS CONFIRMED A LEAK IN THE OXYGENATOR HEAT EXCHANGER. THE OXYGENATOR WAS RETURNED TO SORIN GROUP ITALIA FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WITH SORIN GROUP ITALIA'S FINDINGS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PERFUSIONIST NOTED THAT THE WATER IN THE HEATER/COOLER HAD A RED TINGE TO IT. HE CONTINUED TO USE THE OXYGENATOR TO COMPLETE THE CASE. THERE WERE NO ILL EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NE HRT HSP LINCOLN, NE1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 0804200082

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR