BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 12778752 · Received November 9, 2021

    Report

    Report Number
    1722028-2021-00355
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    January 17, 2021
    Report Date
    November 8, 2021
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    UDI-DI
    05020583824461
    PMA / PMN Number
    BK190332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE PRODUCT WAS NOT RETURNED AND THEREFORE AN EVALUATION COULD NOT BE CONDUCTED. THE CUSTOMER PROVIDED A RUN SUMMARY REPORT LISTING THE PRODUCT INFORMATION AND ALARMS DURING THE PROCEDURE. THERE WERE SEVERAL 'DRAW PRESSURE TOO LOW' ALARMS AND THE OPERATOR MADE SEVERAL ADJUSTMENTS TO DECREASE THE DRAW FLOW RATE. THE PROCEDURE WAS COMPLETED AND THE PRODUCT WAS LABELED AS LEUKOREDUCED. A DISPOSABLE COMPLAINT HISTORY SEARCH WAS PERFORMED FOR THIS LOT AND FOUND NO OTHER REPORTS FOR SIMILAR ISSUES ON THIS LOT. ACCORDING TO THE AABB CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD COMPONENTS (REVISED 2017), FEBRILE NONHEMOLYTIC REACTIONS ARE TYPICALLY MANIFESTED BY A TEMPERATURE ELEVATION OF >1C OR 2F OCCURRING DURING OR WITHIN 4 HOURS AFTER A TRANSFUSION AND IN THE ABSENCE OF ANY OTHER PYREXIC STIMULUS OR ACTIVE WARMING. FEBRILE REACTIONS MAY OCCUR IN LESS THAN 1% OF TRANSFUSION OF LEUKOCYTE-REDUCED RED CELL COMPONENTS AND ABOUT 5% OF LEUKOCYTE-REDUCED APHERESIS PLATELET COMPONENTS. FEBRILE REACTIONS OCCUR MORE FREQUENTLY IN PATIENTS RECEIVING NON-LEUKOCYTE-REDUCED COMPONENTS AND THOSE PREVIOUSLY "ALLOIMMUNIZED" BY TRANSFUSION OR PREGNANCY. ANTIPYRETICS USUALLY PROVIDE EFFECTIVE SYMPTOMATIC RELIEF. PATIENTS WHO EXPERIENCE REPEATED, SEVERE FEBRILE REACTIONS MAY BENEFIT FROM RECEIVING LEUKOCYTE-REDUCED COMPONENTS. IF THESE REACTIONS ARE CAUSED BY CYTOKINES IN THE COMPONENT, PRESTORAGE LEUKOCYTE REDUCTION MAY BE BENEFICIAL. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE FEBRILE NON-HEMOLYTIC TRANSFUSION REACTION. THE REPORTED ADVERSE EVENTS ARE COMMON SIDE EFFECTS OF TRANSFUSION. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT IT IS LIKELY DUE TO ONE OR A COMBINATION OF THE POSSIBLE CAUSES LISTED BELOW: THE ACTION OF ANTIBODIES AGAINST WHITE CELLS OR THE ACTION OF CYTOKINES EITHER PRESENT IN THE TRANSFUSED COMPONENT OR GENERATED BY THE RECIPIENT IN RESPONSE TO TRANSFUSED ELEMENTS. PATIENTS RECEIVED NON-LEUKOCYTE-REDUCED COMPONENTS. PATIENTS WERE PREVIOUSLY "ALLOIMMUNIZED" BY TRANSFUSION. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE MICROBIAL CONTAMINATION. THE ROOT CAUSE WAS DETERMINED TO BE AN OPERATOR ERROR WHERE THE CONTAMINANTS WERE INADVERTENTLY INTRODUCED POST TRANSFUSION DURING TESTING.

    Description of Event or Problem · 0

    A REPRESENTATIVE OF THE CERUS CORPORATION, SHARED A MEDWATCH 3003925919-2021-00004 WITH A TERUMO BCT ASSOCIATE DURING A CONVERSATION. THE REPORT IS OF A PLATELET COLLECTION AT A (B)(6). THE PLATELET WAS SUBSEQUENTLY INTERCEPT TREATED ON (B)(6) 2021. THEN TRANSFUSED AND THE PEDIATRIC RECIPIENT EXPERIENCED A NON-SERIOUS EVENT OF FEBRILE NON-HEMOLYTIC TRANSFUSION REACTION'. THEN ON (B)(6) 2021, A POSITIVE CULTURE RESULT ON A SAMPLE TAKEN FROM THE INTERCEPT PLATELET TRANSFUSION BAG WAS REPORTED TO THE PATIENT'S CLINICIAN.' IT DOES NOT APPEAR THE BACTERIAL CONTAMINATION WAS PREVIOUSLY REPORTED TO (B)(6), HAVE ALLEGED THAT THE TRIMA SYSTEM PLAYED A ROLE IN THE BACTERIAL CONTAMINATION. FULL PATIENT ID: (B)(6) PATIENT WEIGHT AND OUTCOME ARE UNKNOWN. THE ASSOCIATED MEDWATCH LISTS THE PATIENT REACTION AS 'NON-SERIOUS' THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A REPRESENTATIVE OF THE CERUS CORPORATION, SHARED A MEDWATCH 3003925919-2021-00004 WITH A TERUMO BCT ASSOCIATE DURING A CONVERSATION. THE REPORT IS OF A PLATELET COLLECTION AT A VERSITI BLOOD CENTER OF INDIANA. THE PLATELET WAS SUBSEQUENTLY INTERCEPT TREATED ON (B)(6) 2021. THEN TRANSFUSED AND THE PEDIATRIC RECIPIENT EXPERIENCED A 'NON-SERIOUS EVENT OF FEBRILE NON-HEMOLYTIC TRANSFUSION REACTION'. THEN 'ON (B)(6) 2021, A POSITIVE CULTURE RESULT ON A SAMPLE TAKEN FROM THE INTERCEPT PLATELET TRANSFUSION BAG WAS REPORTED TO THE PATIENT'S CLINICIAN.' IT DOES NOT APPEAR THE BACTERIAL CONTAMINATION WAS PREVIOUSLY REPORTED TO TERUMO BCT. NEITHER CERUS, NOR VERSITI BLOOD CENTER OF INDIANA, HAVE ALLEGED THAT THE TRIMA SYSTEM PLAYED A ROLE IN THE BACTERIAL CONTAMINATION. FULL PATIENT ID: (B)(6). PATIENT WEIGHT AND OUTCOME ARE UNKNOWN. THE ASSOCIATED MEDWATCH LISTS THE PATIENT REACTION AS 'NON-SERIOUS' THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675400 TRIMA ACCEL TRIMA PLATELET+SAMPLER, PLASMA, RBC SET GKT TERUMO BCT 82446 2009164151 05020583824461

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Other