BEUDAMED
    FDA Adverse Event Death Summary report: N

    0.8% SURG 3X10ML

    MDR report key: 16215744 · Received January 20, 2023

    Report

    Report Number
    0002250051-2023-00037
    Event Type
    Death
    Date Received
    January 20, 2023
    Date of Event
    August 3, 2021
    Report Date
    January 20, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    QHT
    UDI-DI
    10758750007660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER REPORTED A PATIENT DEATH DUE TO NEGATIVE ANTIBODY SCREENING RESULTS. TESTING WAS PERFORMED ON THREE ORTHO VISION ANALYZERS ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021 AND NEGATIVE ANTIBODY SCREENING RESULTS WERE CONFIRMED. COLD AGGLUTINATION STUDIES WERE PERFORMED AND A COLD ANTIBODY WAS IDENTIFIED INCLUDING A POSITIVE AUTOCONTROL WHICH BECAME NEGATIVE AT 30 DEGREES C. PATIENT WITH HISTORY OR BREAST CANCER AND MITRAL REGURGITATION OF PULMONARY VEIN, WAS TAKEN TO SURGERY ON (B)(6) 2021. AFTER A MASSIVE TRANSFUSION PROTOCOL WAS ACTIVATED, THE PATIENT EXPIRED DURING SURGERY. CUSTOMER INDICATES THAT THE PATIENT WAS ALREADY IN DEMISE BEFORE ANY TRANSFUSION AND THAT THE PATIENT'S DEATH WAS NOT TRANSFUSION RELATED. (B)(4).

    Description of Event or Problem · 0

    MXP2493870; RA600634 CUSTOMER REPORTED A PATIENT DEATH DUE TO NEGATIVE ANTIBODY SCREENING RESULTS. TESTING WAS PERFORMED ON THREE ORTHO VISION ANALYZERS ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021 AND NEGATIVE ANTIBODY SCREENING RESULTS WERE CONFIRMED. COLD AGGLUTINATION STUDIES WERE PERFORMED AND A COLD ANTIBODY WAS IDENTIFIED INCLUDING A POSITIVE AUTOCONTROL WHICH BECAME NEGATIVE AT 30 DEGREES C. PATIENT WITH HISTORY OR BREAST CANCER AND MITRAL REGURGITATION OF PULMONARY VEIN, WAS TAKEN TO SURGERY ON (B)(6) 2021. AFTER A MASSIVE TRANSFUSION PROTOCOL WAS ACTIVATED, THE PATIENT EXPIRED DURING SURGERY. CUSTOMER INDICATES THAT THE PATIENT WAS ALREADY IN DEMISE BEFORE ANY TRANSFUSION AND THAT THE PATIENT'S DEATH WAS NOT TRANSFUSION RELATED. ORTHO INVESTIGATION: BATCH RECORD REVIEW AND A COMPLAINT REVIEW WERE PERFORMED. RETAIN SAMPLES HAD ALREADY EXPIRED. ALL RESULTS WERE AS EXPECTED. THE ORDER REPORTS FOR TESTING PERFORMED ON THE CUSTOMER'S ORTHO VISION ID-MTS ANALYZERS WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER. ORTHO'S MEDICAL SAFETY OFFICER WAS CONSULTED ON THIS CASE AND PROVIDED THE FOLLOWING RESPONSE: BASED ON THE AVAILABLE INFORMATION, MULTIPLE TYPE AND SCREENING TESTS WERE DONE FOR THIS PATIENT AND GENERATED O POSITIVE AND ANTIBODY SCREENING NEGATIVE RESULTS. HOWEVER, COLD REACTIVITY WAS DETECTED USING ORTHO METHOD AND POSITIVE ANTIBODY SCREENING WAS ALSO OBTAINED USING A NON-ORTHO METHOD AND AN ANTI-P1 WAS IDENTIFIED FOR THIS PATIENT. ANTI-P1 IS TYPICALLY A CLINICALLY INSIGNIFICANT IGM ANTIBODY THAT DOES NOT REACT AT TEMPERATURES >25 °C. THE PATIENTS RECEIVED MULTIPLE CROSSMATCHED AND PREWARMED RED BLOOD CELL UNITS ON (B)(6) 2021. ON (B)(6) , THE PATIENT WAS IN SURGERY LATER DIED. NO INFORMATION TO SUGGEST THE PATIENT EXPERIENCED A HEMOLYTIC TRANSFUSION REACTION WHEN RECEIVED THE MASSIVE TRANSFUSION DURING THE SURGERY. IT IS HIGHLY UNLIKELY PATIENT'S DEATH WAS CAUSED BY THE ANTI-P1 ANTIBODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895381 0.8% SURG 3X10ML REAGENT RED BLOOD CELLS QHT ORTHO-CLINICAL DIAGNOSTICS, INC. 6902316 MULTIPLE LOTS: VSS297, VSS302 10758750007660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death