BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FENWAL

    MDR report key: 2362674 · Received December 2, 2011

    Report

    Report Number
    MW5023309
    Event Type
    Injury
    Date Received
    December 2, 2011
    Date of Event
    October 31, 2011
    Report Date
    December 2, 2011
    Manufacturer
    FENWAL INC.
    Product Code
    GKT
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PLATELET DONOR WAS OVER COLLECTED ON AN AMICUS PLATELET SEPARATOR. THE AMOUNT OF PLASMA COLLECTED INCLUDED ADDITIONAL PLASMA VOLUME THAT LEAKED INTO THE COLLECTION BAG DURING THE COLLECTION PROCESS. THE TOTAL PLASMA LOSS FOR THE DONOR WAS 856MLS. THE DONOR WEIGHS (B)(6), AND IS LIMITED TO 600MLS OF PLASMA LOSS PER DONATION. AMICUS TECHNICAL SUPPORT WAS CONTACTED AND THE MACHINE WAS TAKEN OUT OF SERVICE. THE SERVICE TECHNICIAN IS COMING IN ON (B)(6) 2011 TO DETERMINE THE CAUSE OF THE PROBLEM - FAULTY VALVE, KIT, ETC. PLATELET PRODUCT WAS DISPOSED, AND DONOR WAS DEFERRED FOR FOUR WEEKS. DONOR WAS CONTACTED THE FOLLOWING DAY TO ENSURE THAT SHE HAD NO ADVERSE REACTIONS. DONOR REPORTED FEELING WELL AND HEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENWAL AMICUS GKT FENWAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R