BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASMACELL-C DISPOSABLE SET

    MDR report key: 889212 · Received August 1, 2007

    Report

    Report Number
    9612051-2007-00001
    Event Type
    Injury
    Date Received
    August 1, 2007
    Date of Event
    June 15, 2007
    Report Date
    June 25, 2007
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PHLEBOTOMIST, THERE WAS A COLOR CHANGE IN THE PLASMA LINE, NOTED PRIOR TO THE EXPECTED ALARM. THE PROCEDURE WAS MONITORED AND SINCE THE COLOR DID NOT CLEAR, THE PROCEDURE WAS STOPPED. ONCE THE PROCEDURE WAS STOPPED, THE ALARM FOR HB DETECT SOUNDED AND THE DONOR WAS IMMEDIATELY DISCONTINUED FROM THE COLLECTION PROCESS WITHOUT INFUSION OF RED CELLS. THE CENTER MANAGEMENT INDICATED THE PLASMA UNIT COLLECTED IN 2007, WAS DESTROYED DUE TO RED COLOR. THERE IS NO SAMPLE AVAILABLE FOR EVALUATION AS THE CENTER DISCARDED KIT INTO THE BIOHAZARDOUS WASTE RECEPTACLE ON THE SAME DAY OF DONATION. A REVIEW OF THE PLASMA CENTER'S DONOR HISTORY RECORD AND THE DONOR'S LAST ANNUAL MEDICAL HISTORY AND PHYSICAL EXAMINATION (2007) REVEALED THIS DONOR TO BE A QUALIFIED PLASMAPHERESIS DONOR WHO HAS MET ALL THE REQUIREMENTS FOR PLASMAPHERESIS. REVIEW OF THE PLASMAPHERESIS INSTRUMENT TROUBLE SHOOTING LOG, INDICATED, NOTED DOCUMENTATION OF 'RED PLASMA, UNABLE TO CLEAR, DONOR DISCONTINUED', FOR THE DAY OF THE DONATION. THE AUTOPHERESIS-C INSTRUMENT IN USE DURING THIS INCIDENT WAS PULLED FROM SERVICE AND EVALUATED AT THE REQUEST OF THE PLASMA CENTER'S HEADQUARTERS. THE INSTRUMENT WAS FOUND TO BE FUNCTIONING AS INTENDED AND RETURNED TO SERVICE. A REVIEW OF MANUFACTURERS BATCH RECORDS DID NOT REVEAL ANY MANUFACTURING DEFECTS THAT WOULD CONTRIBUTE TO THIS REPORTED EVENT. A REVIEW OF THE FENWAL COMPLAINT DATABASE DID NOT REVEAL ANY SIMILAR REPORTS FOR THIS LOT OF PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SOURCE PLASMA DONATION CENTER THAT A PLASMAPHERESIS PROCEDURE FOR THIS DONOR WAS DISCONTINUED WHEN ONLY 157 ML PLASMA HAD BEEN COLLECTED, DUE TO RED PLASMA COLOR NOTED IN THE DISPOSABLE SET PLASMA LINE. FOLLOWING DISCONNECTION, THE DONOR REPORTED RED COLOR URINE PRIOR TO HIS LEAVING THE CENTER. THE DONOR DENIED ANY BACK PAIN OR ANY OTHER SIGNS AND SYMPTOMS. THE DONOR WAS ADVISED TO DRINK PLENTY OF FLUIDS AND TO SEEK MEDICAL EVALUATION. AFTER LEAVING THE CENTER THE DONOR DID SEEK MEDICAL EVALUATION, AS ADVISED, AT A LOCAL EMERGENCY ROOM (ER). THE DIAGNOSIS INDICATED ON MEDICAL RECORDS INDICATED HEMOGLOBINURIA STATUS POST PLASMA DONATION. THE DONOR DID NOT COMPLAIN OF ANY ASSOCIATED SYMPTOMS AT THE ER, AND WAS HOSPITALIZED OVERNIGHT FOR IV HYDRATION AND RELEASED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMACELL-C DISPOSABLE SET AUTOPHERESIS-C KITS GKT FENWAL, INC. NA A07D02084

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization LOT# C707984)| BAG (LOT #C709246)| 4B7867Q-ANTICOAGULANT SODIUM CITRATE USP 250 ML| 4R4550-AUTOPHERESIS-C INSTRUMENT| 2B1323N-0.9% SODIUM CHLORIDE INJ USP| (SERIAL# 206T11975)