BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6143166 · Received December 2, 2016

    Report

    Report Number
    1722028-2016-00624
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PHYSICIAN STATED THAT THEY CHECKED THE COLLECTION SET FOR OBSTRUCTIONS. NO OBSTRUCTIONS WERE OBSERVED IN THE TUBING LINES. TERUMO BCT'S SERVICE TECHNICIAN CHECKED THE RBC DETECTOR'S FUNCTIONALITY AND CALIBRATION WITH NO ISSUES FOUND. AN AUTOTEST WAS SUCCESSFULLY PERFORMED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR IS THERE A LIKELY POTENTIAL FOR DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. DURING CUSTOMER FOLLOW-UP, THE CUSTOMER STATED THAT THEY DO NOT ALLEGE AND/OR SUSPECT HEMOLYSIS IN THE PLASMA LINE. PERTHE PHYSICIAN, IT WAS WHOLE BLOOD, AS EXPECTED. INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: PER INTERNAL REPORT, NO ADDITIONAL ISSUES HAVE BEEN REPORTED FOR THIS MACHINE REGARDING THE REPORTED CONDITION. THE CUSTOMER CONFIRMED THAT THERE WAS WHOLE BLOOD IN THE PLASMA BAG WITH NO HEMOLYSIS. ROOT CAUSE: THE ROOT CAUSE OF THIS EVENT WAS WHOLE BLOOD IN THE PLASMA LINE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION AND CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLLECTION PROCEDURE, THEY RECEIVED 'HEMOLYSIS DETECTED' ALARM AND OBSERVED RED TINGE ON THE PLASMA LINE. NO TESTING WAS PERFORMED TO CONFIRM THE ALLEGED HEMOLYSIS. PATIENT INFORMATION AND OUTCOME ARE NOT KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793423 TRIMA ACCEL TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM GKT TERUMO BCT 81000

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Other