BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORFOLK GENERAL NORFOLK VA 1

    MDR report key: 1713459 · Received June 1, 2010

    Report

    Report Number
    1718850-2010-00110
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 4, 2010
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE PERFUSIONIST NOTICED A PINK TINGE IN THE PVC CARDIOPLEGIA COIL ICE BATH. THE PT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. THERE WAS NO PT INJURY REPORTED. RISK MANAGEMENT WAS CONTACTED. SHE STATED THAT THE PERFUSIONIST COULD NOT SEE ANY ABNORMALITIES OR OBVIOUS HOLES IN THE TUBING. WHEN THE TUBING WAS PRESSURIZED, A SMALL LEAK WAS SEEN IN THE COIL. A SORIN GROUP REP WAS ALLOWED TO VISUALLY INSPECT THE PVC COIL WITH RISK MANAGEMENT. THE PERFUSIONISTS OBSERVATION WAS CONFIRMED, NO OBVIOUS ABNORMALITIES COULD BE SEEN. THE PVC COIL WAS NOT RETURNED TO SORIN GROUP USA FOR EVALUATION. NO TESTING WAS PERFORMED. TWO PVC COILS WERE PULLED FROM PRODUCTION INVENTORY. NO ABNORMALITIES WERE SEEN DURING VISUAL INSPECTION. PRESSURE TESTING AT 15 PSI FOR FOUR HOURS DID NOT PRODUCE ANY LEAKS. THERE HAVE BEEN NO OTHER REPORTS OF FAILURES WITH THE PVC COILS. SINCE THE DEVICE WAS NOT RETURNED, THE CAUSE OF THE LEAK CAN NOT BE DETERMINED. NO FURTHER ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PERFUSIONIST NOTICED A PINK TINGE IN THE PVC CARDIOPLEGIA COIL ICE BATH. THE PT WAS GIVEN ANTIBIOTICS AS A PRECAUTION. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORFOLK GENERAL NORFOLK VA 1 CUSTOM PERFUSION PACK DWE SORIN GROUP USA, INC. NA 1007600030

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR