BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1952169 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00089
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    November 10, 2008
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RISK ANALYSIS: NO ADVERSE HEALTH EFFECTS HAVE BEEN OBSERVED OF THE DONOR AT THE TIME OF PROCEDURE OR IMMEDIATELY AFTER DISCONTINUING THE RUN. F/U CONFIRMED DONOR'S CONTINUED HEALTH ON (B)(6) 2008. FIELD DIAGNOSTIC/CORRECTION: PER THE BLOOD CENTER'S PROCEDURES, THE PRODUCT WAS LABELED QNS AND DESTROYED. A SERVICE CALL WAS PLACED FOR INVESTIGATING THE MACHINE FOR PROPER FUNCTION. THE RDF FILES WERE DOWNLOADED FOR THE DATE OF THE PROCEDURE IN QUESTION ((B)(6) 2008). ROOT CAUSE: THERE WAS NO FAILURE OF THE TRIMA TO MEET THE MFG SPECIFICATIONS. NO OTHER SIMILAR EVENTS FOR THIS LOT NUMBER HAVE BEEN REPORTED TO DATE. TRENDS SUGGEST THAT THE EVENT REPORTED IS RANDOM AND ISOLATED ON A GENERAL BASIS. TRENDS ARE REGULARLY MONITORED TO DETERMINE APPROPRIATE CORRECTIVE ACTIONS BY MFG OR ENGINEERING. A SAMPLE OF THE COLLECTED WASTE PLASMA WAS SPUN DOWN IN A CENTRIFUGE TO EVALUATE IF HEMOLYSIS HAD OCCURRED, RESULTS WERE INCONCLUSIVE. BLOOD CENTER MEDICAL DIRECTOR STATED THAT LACK OF EVIDENCE EXISTED TO CONFIRM HEMOLYSIS OCCURRED. (B)(4) ANALYSIS SHOWED NO DISCERNIBLE SIGNAL INDICATING HEMOLYSIS OCCURRED. MACHINE VERIFIED DURING SERVICE CALL TO BE ACCEPTABLE FOR USE AFTER PASSING BATTERY OF TESTS CONDUCTED. OUT OF SERVICE UNTIL SERVICE CALL COMPLETED ON (B)(6) 2008. CONCLUSION: DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE CUSTOMER CALLED WITH CONCERNS THAT THERE MIGHT HAVE BEEN SOME HEMOLYSIS IN THE DISPOSABLE DURING ONE OF THEIR PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 09P1304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK