BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMACELL-C DISPOSABLE SET W/1000 ML BAG

    MDR report key: 384163 · Received March 22, 2002

    Report

    Report Number
    1420141-2002-00012
    Event Type
    Injury
    Date Received
    March 22, 2002
    Date of Event
    January 3, 2002
    Report Date
    March 22, 2002
    Manufacturer
    DOMINICAN REPUBLIC
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 02/2002, BAXTER EUROPE RECEIVED A LETTER FROM DR. INFORMING BAXTER OF AN ISSUE WITH A DONOR AFTER A PLASMAPHERESIS PROCEDURE PERFORMED. IN 02/2002 DR. RECEIVED A MESSAGE THAT A PLASMAPHERESIS DONOR WAS SHOWING A DEEP VEIN THROMBOSIS THAT POSSIBLY WAS RELATED TO PLASMAPHERESIS PROCEDURE PERFORMED A MONTH EARLIER. A COUPLE OF DAYS AFTER THE DONATION THE DONOR COMPLAINED OF PAIN AT THE DISTAL LOCATION OF THE VENIPUNCTURE SITE. THE DONOR VISITED THEIR WORK PHYSICIAN WHERE NON-STERIOD ANTI-INFLAMMATORY DRUGS WERE GIVEN (NSAID). THE DONOR RETURNED TO THE CENTER BECAUSE THE PAIN PERSISTED. THE DONOR WAS REFERRED TO THEIR PERSONAL PHYSICIAN WHO PRESCRIBED ANTIBIOTICS APART FROM THE NSAID'S. SINCE THE PAIN PERSISTED AND SMALL SWELLING WAS ON THE HAND AND FOREARM THE DONOR WAS REFERRED TO A VASCULAR SURGEON. INVESTIGATION OF THE DONOR REVEALED THAT THE DONOR HAD A DEEP VENOUS THROMBOSIS APPROX 10 CM PROXIMAL OF THE VENIPUNCTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMACELL-C DISPOSABLE SET W/1000 ML BAG AUTOPHERESIS-C KITS GKT DOMINICAN REPUBLIC NA A01I16253

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization INSTRUMENT NR 9108D.| NEEDLE: 01G02-1, CITRATE 01K09A3, SALINE H01I24A7