BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMALINK TRANSFER PACK

    MDR report key: 1520320 · Received October 23, 2009

    Report

    Report Number
    3004548776-2009-00003
    Event Type
    Malfunction
    Date Received
    October 23, 2009
    Date of Event
    September 24, 2009
    Report Date
    September 24, 2009
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED TRANSFER PACK WAS RECEIVED. IT WAS OBSERVED THAT A HEAT SEAL HAD BEEN APPLIED TO THE TRANSFER PACK POST-DONATION. VISUAL INSPECTION OF THE BAG SHOWED A TEAR IN THE BUSHING WHERE THE TRANSFER TUBE IS ASSEMBLED. IT APPEARED THAT THE TUBING WAS NOT COMPLETELY INSERTED INTO THE TOP SEAL AREA, AND DURING HANDLING, THE BUSHING CRACKED.

    Description of Event or Problem · 1

    AT APPROX 12:10 PM, A "FREQUENT PLASMA DONOR" WAS DONATING ON THE AUTO-C INSTRUMENT. VITAL SIGNS PRIOR TO THE PROCEDURE WERE BLOOD PRESSURE (B/P) OF 123/74 MMHG AND PULSE OF 64. THE PROGRAMMED PLASMA VOLUME WAS 825 ML. THEN, DURING THE PROCEDURE, THE DONOR REPORTED THAT THE PLASMA COLLECTION WAS TAKING LONGER THAN USUAL. THE OPERATOR THEN NOTED PLASMA ON THE FLOOR IN AN AREA OF APPROX 4' BY 4'. THE DONOR WAS DISCONNECTED FROM THE INSTRUMENT, RESULTING IN A LOSS OF 129 ML OF RED BLOOD CELLS (RBC). THE DONOR BECAME NAUSEATED AND REPORTED BLURRED VISION. INITIALLY, SHE WAS GIVEN ORAL FLUIDS; HOWEVER, THE SYMPTOMS DID NOT ABATE. AN INTRAVENOUS LINE WAS INSERTED INTO THE DONOR TO ADMINISTER A TOTAL OF 1000 ML OF NORMAL SALINE. THE OPERATOR ESTIMATED THAT THE DONOR LOST APPROX 1000 ML OF PLASMA AND THE ADD'L 129 ML OF RBC FROM THE KIT. THE DONOR WAS GIVEN ADD'L ORAL FLUIDS AND SNACKS. VITAL SIGNS PRIOR TO RELEASE FROM THE CENTER WERE 121/55 MMHG AND PULSE OF 67. THE DONOR RECOVERED WITH NO SEQUELAE. THE DONOR WAS CALLED LATER BY THE CENTER AND THE DONOR REPORTED SHE FELT "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMALINK TRANSFER PACK EMPTY CONTAINER FOR PLASMA COLLECTION GKT FENWAL, INC. NA FA09H10045

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention