BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC, PAS, TLR SET

    MDR report key: 2623700 · Received June 11, 2012

    Report

    Report Number
    1722028-2012-00354
    Event Type
    Other
    Date Received
    June 11, 2012
    Date of Event
    April 1, 2012
    Report Date
    May 15, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK970005
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THIS SET WAS NOT AVAILABLE FOR A SPECIFIC ROOT CAUSE ANALYSIS, CORRECTIVE AND PREVENTATIVE ACTIONS BY QUALITY ASSURANCE. INCOMING INSPECTION FOR THE RAW MATERIAL CITRATE FILM USED TO MANUFACTURE THE EXTENDED LIFE PLATELET (ELP) BAGS HAS BEEN ONGOING SINCE (B)(6) 2009. ROOT CAUSE: DEFINITIVE ROOT CAUSE REMAINS UNDETERMINED, BUT MAY BE RELATED TO: PLATELET STORAGE TEMPERATURE, INADEQUATE ANTICOAGULATION OF THE DISPOSABLE SET DURING PROCESSING CAN CAUSE PLATELET AGGREGATION. THIS CAN BE RELATED TO THE INLET:AC RATIO AT WHICH THE MACHINE IS CONFIGURED. PATIENT SPECIFIC VARIABLES. COLLECTION OF PLATELETS AT HIGH CONCENTRATIONS. CORRECTIVE/PREVENTIVE ACTION: REDUCING THE INLET:AC RATIO CAN IN SOME CASES REDUCE THIS ISSUE , AS IT ALLOWS BETTER ANTICOAGULATION OF THE SYSTEM. IN THE EVENT THAT PLATELET AGGREGATION IS APPARENT IMMEDIATELY AFTER COLLECTION, THE PRODUCT SHOULD BE LEFT TO REST, LABEL SIDE DOWN, FOR 1 HOUR BEFORE PLACING IT ON A ROTATOR. IT IS WORTH NOTING THE IMPORTANCE OF A TEMPERATURE CONTROLLED ENVIRONMENT (ROOM AND SURFACE) FOR POST-COLLECTION RESTING TO DISPERSE AGGREGATES. WARMER IS BETTER BUT NOT TO EXCEED 24C AND NO EXPOSURE TO DRAFTS (VENTS, DOORS OR HIGH TRAFFIC AREAS).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION FROM THE CUSTOMER INDICATES THAT STARTING JUNE 1, 2011, PLATELET FILTRATION IS CONDUCTED AT DAY 1 RATHER THAN 2 HOURS AFTER COLLECTIONS, IN ORDER TO DIMINISH THE PRESENCE OF AGGREGATES. THE CUSTOMER PROVIDED SEVERAL LOT NUMBERS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THESE UNITS SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    AGGREGATION OCCURRED POST COLLECTION, SO THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED WHEN THE AGGREGATION WAS FOUND. THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AGGREGATES, GENERATING A PLATELET PRODUCT LOSS OF 60X FROM (B)(6) 2011 TO (B)(6) 2012. NO ALARMS. PT INFO IS NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL COMPETENT AUTHORITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC, PAS, TLR SET AUTOMATED BLOOD CELL SEPARATOR LKN TERUMO BCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1