BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 UNIT RED CELL SET W/RC2H FIL

    MDR report key: 12711245 · Received October 28, 2021

    Report

    Report Number
    1219343-2021-00136
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 27, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    UDI-DI
    10812747013512
    PMA / PMN Number
    BK060023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, HAEMONETICS MANUFACTURING PERFORMED A VISUAL INSPECTION OF THE RETURNED SAMPLE AND IT WAS CONFIRMED THAT THE CONFIGURATION OF THE UNIT IS CORRECT (ALL COMPONENTS ARE CORRECTLY ASSEMBLED). KINKS WERE FOUND THROUGHOUT THE ALL TUBING HOWEVER, SINCE THE RETURNED SAMPLE WAS RECEIVED WITH THE TUBING'S COILED, IT IS NOT POSSIBLE TO CONFIRM IF THESE KINKS WERE GENERATED DUE TO THE WAY THE SAMPLE WAS RETURNED OR FOR OTHER REASON. A VISUAL EVALUATION WAS CONDUCTED AND IT WAS FOUND THAT THE 6 FILTER HOLES ARE NOT BLOCKED. BOTH SIDES OF THE FILTER WERE CHECKED AND THERE ARE NO TRACES OF SOLVENT ON EITHER SIDE. THE MEDIA IS DAMAGED WITH ONE HOLE CLOSE TO THE OUTLET.

    Description of Event or Problem · 1

    ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF WEIGHT CHANGING TOO SLOWLY IN RBC TRANSFER, WEIGHT CHANGING TO SLOWLY IN PLASMA RETURN, AIR DETECTED AT BLAD ALARMS DURING RETURN AND POSSIBLE RBC SPILL DURING DRAW ALARMS UTILIZING A 2 UNIT RED CELL SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611711 2 UNIT RED CELL SET W/RC2H FIL 2 UNIT RED CELL SET W/RC2H FIL GKT HAEMONETICS CORPORATION 0832F-00 0321042 10812747013512

    Patients

    Seq Age Sex Outcome Treatment
    1