BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC SET

    MDR report key: 2453711 · Received February 10, 2012

    Report

    Report Number
    1722028-2012-00078
    Event Type
    Other
    Date Received
    February 10, 2012
    Date of Event
    October 7, 2012
    Report Date
    January 16, 2012
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: PER THE CUSTOMER, DURING THE DONATION THE DONOR EXPERIENCED SOME ACCESS FLOW ALARMS, AND HAD ISSUES WITH CLUMPING. THE OPERATOR DECREASED THE CLUMPING BUTTON TWICE. SHE NOTED INTERMITTENT ACCESS PRESSURE LOW ALARMS THROUGHOUT THE RUN. THE DONATION WAS DISCONTINUED WITHOUT INCIDENT AND THE DONOR WAS RELEASED TO GO HOME. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD WAS REVIEWED. NOTHING WAS FOUND THAT WAS RELATED TO THIS EVENT. A REVIEW OF TRIMA REACTIONS WAS PERFORMED BY THE TERUMO BCT CLINICAL SCIENTIFIC GROUP. BASED ON THE DATA REVIEWED, THERE HAS NOT BEEN AN INCREASE IN DONOR REACTIONS RELATED TO LOSS OF CONSCIOUSNESS. THE CUSTOMER'S PROCEDURAL DATA WAS ALSO COMPARED TO THE NATIONAL AVERAGE. THE CUSTOMER HAS MORE THREE-PRODUCT PROCEDURES THAN THE NATIONAL AVERAGE, BUT DOES NOT HAVE FOUR- AND FIVE-PRODUCT PROCEDURES AS OTHER CUSTOMERS DO. THE TOTAL VOLUMES COLLECTED ARE WITHIN THE SAFETY LIMIT OF 15% OF THE DONOR'S TOTAL BLOOD VOLUME. TERUMO BCT DOES NOT BELIEVE THAT THE CUSTOMER'S COLLECT VOLUMES PUT DONORS AT INCREASED RISK FOR LOSS OF CONSCIOUSNESS EVENTS. PER THE TRIMA OPERATOR'S MANUAL, THE TRIMA ACCEL SYSTEM HAS MANY SAFETY FEATURES. HOWEVER, A DONOR REACTION CAN OCCUR RAPIDLY. THEREFORE, IT IS IMPERATIVE THAT THE TRIMA ACCEL SYSTEM AND THE DONOR BE MONITORED THROUGHOUT THE PROCEDURE. THE MANUAL FURTHER ADVISES THE CUSTOMER TO BE AWARE OF POSSIBLE DONOR REACTIONS. SOME DONOR REACTIONS THAT HAVE BEEN PREVIOUSLY REPORTED FOR WHOLE BLOOD DONATIONS OR AUTOMATED COLLECTION PROCEDURES ARE ANXIETY, CHILLS, DIGIT AND/OR FACIAL PARESTHESIA, FEVER, HEADACHE, HEMATOMA, HYPERVENTILATION, HYPOTENSION, LIGHT-HEADEDNESS, NAUSEA AND VOMITING, SYNCOPE (FAINTING), UNPLEASANT TASTE SENSATIONS, URTICARIA, AND ALLERGIC REACTIONS. THE OPERATOR SHOULD BE PREPARED TO TAKE APPROPRIATE ACTION SHOULD ANY OF THESE SYMPTOMS APPEAR. ROOT CAUSE: BASED ON THE ANALYSIS OF THE DATA RELATING TO LOSS OF CONSCIOUSNESS EVENTS, THERE HAS NOT BEEN AN INCREASE IN INCIDENCE AND IT IS NOT BELIEVED THAT THE CUSTOMER'S COLLECTION VOLUMES PUT DONORS AT AN INCREASED RISK. DONOR REACTIONS ARE A KNOWN POSSIBLE SIDE EFFECT OF APHERESIS PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DONOR BECAME UNCONSCIOUS AT HOME THREE HRS POST APHERESIS DONATION. THE DONOR WAS TRANSPORTED TO THE ER VIA AMBULANCE. AN EKG WAS PERFORMED. TESTS WERE PERFORMED TO RULE OUT ANY CARDIAC INVOLVEMENT. IV FLUIDS INCLUDING POTASSIUM WERE GIVEN TO THE DONOR. THE DONOR FOLLOWED UP WITH HIS FAMILY PHYSICIAN (B)(6) WEEKS LATER; HE WAS RELEASED FROM CARE WITH NO RESTRICTIONS. THE DONOR IS STABLE AND HAS DONATED WHOLE BLOOD TWICE SINCE THE INCIDENT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF THE ER VISIT AND ADDITIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 08T3224

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R