BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2922940 · Received January 18, 2013

    Report

    Report Number
    1722028-2013-00023
    Date Received
    January 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 24, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: IN ADDITION TO POSITIVE BACTERIAL CONTAMINATION, THE CUSTOMER ALSO REPORTED THAT THE PH FAILED, AND THE PLATELET CONCENTRATION DROPPED OVER THE LIFE OF THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. PER THE CUSTOMER, THE PLATELET PRODUCT PH FAILED AT PLATELET EXPIRATION ON ((B)(6) 2012). A CULTURE WAS OBTAINED AND THE PRODUCT FAILED FOR BACTERIAL CONTAMINATION ((B)(6) 2012: AN AEROBIC BOTTLE - POSITIVE FOR GRAM NEGATIVE RODS, (B)(6) 2012: ANAEROBIC BOTTLE - POSITIVE FOR GRAM POSITIVE RODS). THE PLATELET CONCENTRATION WAS ALSO MEASURED AND FAILED AT 933E3/UL. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. THERE WERE NO ALERTS OR ADJUSTMENTS DURING THE PROCEDURE. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE ANALYSIS OF THE RUN DATA FILE DID NOT FIND A CONCLUSIVE CAUSE FOR THE LOWER THAN EXPECTED PLATELET PRODUCT PHOR THE POSITIVE BACTERIAL CULTURE. NO UNUSUAL PROCESS VARIABLE WAS IDENTIFIED AND THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT THE BACTERIA COULD HAVE CONTRIBUTED TO THE LOWER THAN EXPECTED PH. IT IS ALSO POSSIBLE THAT THE LOWER THAN EXPECTED PLATELET PRODUCT PH COULD BE THE RESULT OF A SAMPLING OR OTHER PROCESS ERROR, OR COULD BE DONOR RELATED.

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THERE WERE NO UNUSUAL EVENTS DURING THE COLLECTION (E.G. REACTION,MEDICAL INTERVENTION) NOTED ON THE RUN SHEET. THE RESULTS OF THE INITIAL BACTERIAL SCREENING WERE NEGATIVE AFTER 5 DAYS. THE PLATELET PRODUCT WAS NOT NOTED AS TURBID WHEN THE SAMPLE WAS TAKEN ON DAY 6. THERE WERE NO VISIBLE AGGREGATES NOTED IN THE PLATELET PRODUCT WHEN THE SAMPLE WAS TAKEN. THERE WERE NO OTHER CONCURRENT PRODUCTS COLLECTED DURING THE PLATELET COLLECTION. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A PLATELET PRODUCT THAT TESTED POSITIVE FOR BACTERIAL CONTAMINATION. THE CAUSE OF THE CONTAMINATION WAS UNKNOWN. 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 DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27882 TRIMA ACCEL TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET GKT TERUMO BCT 11U1110

    Patients

    Seq Age Sex Outcome Treatment
    1 00000 YR