BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JOSEPHS PHOENIX, AZ 1

    MDR report key: 1485100 · Received July 31, 2009

    Report

    Report Number
    1718850-2009-00029
    Event Type
    Malfunction
    Date Received
    July 31, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 2, 2009
    Manufacturer
    SORIN GROUP USA
    Product Code
    DWF
    PMA / PMN Number
    PRE-AMENDMEN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER FOR THE D100 NEONATAL OXYGENATOR IS K061031. THE D100 IS MANUFACTURED BY SORIN GROUP (B) (4) AND IS A COMPONENT OF THE CUSTOM PERFUSION PACK MANUFACTURED BY SORIN GROUP USA. THE CUSTOM PERFUSION PACK, CATALOG NUMBER 075200200, IS A PRE-AMENDMENT DEVICE. THE PERFUSIONIST REPORTED THAT DURING THE CASE, THE ARTERIAL SAMPLE LINE DISCONNECTED FROM THE OUTLET OF THE OXYGENATOR. THE PERFUSIONIST DID NOT RETURN THE D100 OXYGENATOR FOR EVALUATION OR PROVIDE THE D100 LOT NUMBER INFORMATION. SORIN GROUP (B) (4) HAS BEEN MADE AWARE OF THIS EVENT. WITHOUT THE PRODUCT OR ASSOCIATED LOT NUMBER, THE CAUSE CANNOT BE FURTHER EVALUATED.

    Description of Event or Problem · 1

    THE PERFUSIONIST REPORTED THAT DURING THE PROCEDURE, THE ARTERIAL SAMPLE LINE DISCONNECTED FROM THE OUTLET OF THE OXYGENATOR. A UNIT OF RED CELLS WAS GIVEN TO COMPENSATE FOR THE BLOOD LOSS. THERE WERE NO REPORTS OF INJURY AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JOSEPHS PHOENIX, AZ 1 CUSTOM PERFUSION PACK DWF SORIN GROUP USA NA 0906100155

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO