BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1890837 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00051
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    December 5, 2008
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS KIT WAS NOT AVAILABLE FOR A SPECIFIC ROOT CAUSE ANALYSIS, CORRECTIVE AND PREVENTIVE ACTIONS BY QUALITY ASSURANCE. A DHR REVIEW WAS CONDUCTED. THE REVIEW SHOWED NO MFG ANOMALIES OCCURRED DURING PRODUCTION AND NOTHING OF THIS TYPE OF INCIDENT WAS REPORTED FROM THIS LOT. STERILIZATION RECORD DID NOT SHOW ANY ANOMALIES IN THE PROCESS. A TREND ANALYSIS ON THIS LOT ALSO SHOWED THIS WAS AN ISOLATED INCIDENT, INDICATING NOT DISPOSABLE RELATED ISSUE. THE EQUIPMENT STATUS WAS ALSO EXAMINED. THE PM HISTORY WAS CHECKED AND IT SHOWED A PM WAS PERFORMED IN SEPTEMBER OF 2008 WITHOUT ANY ISSUES. THE MACHINE WAS IN SERVICE FOR THREE MONTHS WHEN THIS INCIDENT OCCURRED. THE RDF WAS DOWNLOADED AND ANALYZED. THE RDF INVESTIGATION FOUND NOTHING OUT OF THE ORDINARY WITH THE RUN. THE PREDICTED FINAL COLLECTED PLATELET VOLUME WAS 434ML AND NO RBC AND PLASMA WAS COLLECTED. THERE WAS NO ADJUSTMENT MADE DURING THE PROCEDURE. THE CUSTOMER HAS SINCE INDICATED THAT THE MACHINE HAS BEEN OPERATING WITHOUT ISSUES AFTER THIS INCIDENT, SUGGESTING THIS IS NOT MACHINE RELATED. THE DONOR IS A REPEAT DONOR FOR DOUBLE PLATELET PRODUCTS. SINCE THE PROCEDURE WAS THE COLLECTION OF PLATELETS AND IT IS BASED ON THE REMOVED PLATELET COUNTS, THE TARGET WAS 6.7X10CELL IN THIS CASE, THE FINAL PLATELET COUNTS IN THE DONOR'S BODY SHOULD NOT HAVE BEEN COMPROMISED FROM ENTERING THE WRONG BODY WEIGHT. ROOT CAUSE: THE OPERATOR WRONGLY ENTERED THE DONOR INFO. THE OPERATOR ENTERED THE DONOR'S WEIGHT AS 312 LBS WHEN THE ACTUAL WEIGHT OF THE DONOR WAS 215 LBS, MISTAKENLY TAKING THE DONOR'S PLATELET PRE-COUNT AS THE DONOR'S WEIGHT.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. THE CUSTOMER ENTERED THE WRONG DONOR INFO, 97 POUNDS HEAVIER THAN THE ACTUAL WEIGHT, BY ENTERING THE DONOR'S PLATELET PRE-COUNT VALUE AS THE DONOR'S WEIGHT, RISKING A POSSIBLE OVER-COLLECTION FROM THE DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PLATELET LKN CARIDIANBCT 81000 10P1109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other