BEUDAMED
    FDA Adverse Event Summary report: N

    LEUKOTRAP RC BLOOD BAGS

    MDR report key: 6140 · Received July 1, 1993

    Report

    Report Number
    6140
    Date Received
    July 1, 1993
    Date of Event
    May 3, 1993
    Report Date
    June 3, 1993
    Manufacturer
    CUTTER BIOLOGICAL - MILES, INC.
    Product Code
    KSR
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    HEMOLYSIS 5 CUTTER LEUKOTRAP RC BAGS WAS OBSERVED SEVERAL DAYS AFTER COLLECTION. THE REPORTS WERE NOT LIMITED TO ONE LOT NUMBERINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEUKOTRAP RC BLOOD BAGS KSR CUTTER BIOLOGICAL - MILES, INC. PRODUCT # 760-63 CA2D58, CA2C15, CA2G66

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data