BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMA ACCEL

    MDR report key: 6449477 · Received March 31, 2017

    Report

    Report Number
    1722028-2017-00102
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 31, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ACCORDING TO AABB TECHNICAL MANUAL 16TH EDITION, ADVERSE EVENTS SEEN AT THE TIME OF DONATION OR THOSE REPORTED LATER AVERAGE ABOUT 3.5% OF DONATIONS. REACTIONS THAT NEED MEDICAL CARE AFTER THE DONOR HAS LEFT THE DONATION SITE ARE SEEN IN 1 IN 3400 DONORS. PER TERUMO BCT'S MEDICAL REVIEW, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THIS INCIDENT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE DONOR'S REACTION COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THE REACTION INCLUDE BUT ARE NOT LIMITED TO DONOR'S PHYSIOLOGY AND/OR DONOR'S SENSITIVITY TO THE PROCEDURE. CITATION: AMERICAN ASSOCIATION OF BLOOD BANKS. (2008). WHOLE BLOOD COLLECTION AND COMPONENT PROCESSING. IN J. D. IN ROBACK MD, PHD, M. R. COMBS MT(ASCP)SBB, B. J. GROSSMAN MD, & C. D.HILLYER MD (EDS.), TECHNICAL MANUAL (16TH ED., PP. 195-196). BETHESDA, MARYLAND: AUTHOR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL METHOD EVALUATION CODES: MANUFACTURING REVIEW C91960, STERILIZATION PROCESS REVIEW C92002 INVESTIGATION: THE DISPOSABLES SET WAS RETURNED TO TERUMO BCT AND EVALUATED. UPON VISUAL INSPECTION, IT WAS CONFIRMED THAT THE SET WAS ASSEMBLED CORRECTLY WITH NO LEAKS, KINKS, OCCLUSIONS OR MISSING PARTS. FLOW OF BLOOD/AC WAS VERIFIED THROUGHOUT THE CASSETTE, CHANNEL, INLET AND RETURN LINES. IN SUMMARY, NO DISPOSABLE DEFECTS WERE IDENTIFIED IN THE RETURNED SET. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE RDF ANALYSIS DID NOT INDICATE THAT THE EVENTS DURING THE PRODUCT COLLECTION CAUSED THE REPORTED DONOR'S RESPONSE. THE TRIMA OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY 31 MINUTES INTO A PLATELET COLLECTION PROCEDURE, A DONOR EXPERIENCED AN ALLERGIC REACTION. PER PHYSICIAN'S ORDER, THE PROCEDURE WAS STOPPED IMMEDIATELY WITHOUT RINSEBACK AND THE DONOR WAS GIVEN 10MG OF CENTIRIZINE ORALLY. WHILE THE DONOR SYMPTOMS DID NOT SUBSIDE, AN AMBULANCE WAS CONTACTED AND THE DONOR WAS TRANSFERRED TO THE HOSPITAL. PATIENT (DONOR) OUTCOME IS NOT AVAILABLE AT THIS TIME. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT (DONOR) INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. DONOR GENDER AND WEIGHT WERE OBTAINED FROM THE RUN DATA FILE (RDF).THIS PRODUCT IS NOT AVAILABLE WITHIN THE US, BUT THIS REPORT IS BEING FILED DUE TO A ALLEGED FAILURE THAT COULD OCCUR ON A SIMILARLY MARKETED DEVICE PLATFORM CLEARED FOR USE BY THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231357 TRIMA ACCEL TRIMA ACCEL LRS PLATELET + AUTOPAS, PLASMA SET GKT TERUMO BCT 11Z9113

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACD-A 750ML, LOT 16BC27020