BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS+9000 WITH PLASMA SET W/FILTERS, BMB

    MDR report key: 13237224 · Received January 12, 2022

    Report

    Report Number
    1219343-2022-00002
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 17, 2021
    Report Date
    December 28, 2021
    Manufacturer
    HAEMONETICS, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK010035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED, THEREFORE, HAEMONETICS IS UNABLE TO PERFORM AN INVESTIGATION AND A CAUSE CAN NOT BE ESTABLISHED. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 1219343-2022-00002-01 IS NOTIFICATION THAT MDR 1219343-2022-00002 WAS SUBMITTED IN ERROR AND NO FUTURE REPORTS INVOLVING THIS PART WILL BE FILED. IT WAS DISCOVERED DURING THE HAEMONETICS INVESTIGATION THAT THE FILTER USED BY THIS CUSTOMER IS PART OF A DISPOSABLE KIT THAT IS SOLD ONLY IN FRANCE. THIS FILTER AND ANY SIMILAR PRODUCTS TO IT ARE NOT SOLD/DISTRIBUTED BY HAEMONETICS IN ANY OTHER MARKET, INCLUDING THE UNITED STATES. THIS SPECIFIC PLASMA COLLECTION RESULTED IN A LOSS OF PRODUCT, THEREFORE, WOULD NOT IMPACT DONOR/USER SAFETY.

    Description of Event or Problem · 0

    ON (B)(6) 2021, HAEMONETICS WAS NOTIFIED OF A NON-COMPLIANCE IN RESIDUAL WHITE BLOOD CELLS DURING SAMPLING PLAN AFTER PLASMA COLLECTION (14490/L) UTILIZING THE MCS+9000 MOBILE COLLECTION SYSTEM AND PLASMA SET. THERE WAS NO REPORT OF DONOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584564 MCS+9000 WITH PLASMA SET W/FILTERS, BMB MCS+9000 WITH PLASMA SET W/FILTERS, BMB GKT HAEMONETICS, INC. 0792P-SL 892118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown