BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL

    MDR report key: 2981155 · Received February 27, 2013

    Report

    Report Number
    1722028-2013-00971
    Event Type
    Other
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. TOTAL RBC PRODUCT COLLECTED WAS BELOW 15% OF TOTAL BLOOD VOLUME. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND ANY CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED RBC PRODUCT VOLUME REPORTED FOR THIS COLLECTION. POSSIBLE ROOT CAUSES WERE PREVIOUSLY PROVIDED IN SUPPLEMENT #1 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND ANY CONCLUSIVE CAUSE FOR THE HIGHER THAN EXPECTED RBC PRODUCT VOLUME REPORTED FOR THIS COLLECTION. SPECIFICALLY, THE SIGNALS FROM THE RETURNED RESERVOIR DO NOT INDICATE ANY DIVERSION OF FLUID FROM THE RETURN RESERVOIR TO THE PRODUCT BAG. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE VOLUME DISCREPANCY COULD HAVE BEEN CAUSED BY A WEIGHING, CALCULATION, OR OTHER PROCESS ERROR. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE REDBLOOD CELL VOLUME DISCREPANCY THAT OCCURRED DURING A TRIPLE PLATELET PRODUCT COLLECTION. PER THE CUSTOMER, THE UNIT WAS OVER THE RECOMMENDED PERCENTAGE DIFFERENCE. THE EXACT VOLUME DISCREPANCY IS NOT KNOWN AT THIS TIME. THE ENTIRE PATIENT IDENTIFIER IS (B)(6). PATIENT AGE, GENDER AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83803 TRIMA ACCEL TRIMA ACCEL PLT, PLS, RBC, AUTO RAS SET GKT TERUMO BCT 12U3110

    Patients

    Seq Age Sex Outcome Treatment
    1