BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3043074 · Received April 9, 2013

    Report

    Report Number
    1722028-2013-01079
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE REPORTED HEMOLYSIS IN THE RBC PRODUCT. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT A PROCESS ERROR MAY HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE RBC BAG AND SEGMENTS WERE RETURNED FOR INVESTIGATION. THE UNIT WAS SHIPPED OVERNIGHT DIRECTLY ON ICE. UPON VISUAL INSPECTION, NO ISSUES WERE NOTED WITH THE PORTION OF THE DISPOSABLE SET THAT WAS RETURNED. HEMOLYSIS TESTING WAS PERFORMED ON THE UNIT AND IT WAS FOUND TO HAVE 0.87% HEMOLYSIS. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE REPORTED HEMOLYSIS IN THE RBC PRODUCT. BASED ON THE AVAILABLE INFORMATION, IT IS LIKELY THAT THE LOW LEVEL OF HEMOLYSIS IN THE UNIT WAS DUE TO PROCESS IN AND/OR STORAGE OF THE UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A RED BLOOD CELL (RBC) UNIT BACK FROM THE HOSPITAL THEY HAD SHIPPED IT TO BECAUSE THE UNIT WAS HEMOLYZED. THE CUSTOMER STATED THAT THERE WASN'T ANY APPEARANCE OF HEMOLYSIS DURING THE COLLECTION OR POST COLLECTION. THE SEGMENTS WERE TESTED BY THE CUSTOMER AND HEMOLYSIS WAS CONFIRMED. THE FULL PATIENT IDENTIFIER IS (B)(6).TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145961 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC, AUTO RAC SET GKT TERUMO BCT 01V3112

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR