BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3182914 · Received June 21, 2013

    Report

    Report Number
    1722028-2013-01256
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK970005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A TERUMO BCT TECHNICIAN CHECKED THE MACHINE'S FUNCTIONING. NO ISSUES WERE FOUND DURING MACHINE CHECKOUT. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED INVESTIGATION: A TERUMO BCT TECHNICIAN CHECKED THE MACHINE'S FUNCTIONING. NO ISSUES WERE FOUND DURING MACHINE CHECKOUT. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE TECHNICAL ERROR HAS NOW BEEN RESOLVED. ADDITIONALLY, PATIENT INFORMATION WAS PROVIDED FROM THE CUSTOMER AND IS INCLUDED INVESTIGATION: A TERUMO BCT TECHNICIAN CHECKED THE MACHINE'S FUNCTIONING. NO ISSUES WERE FOUND DURING MACHINE CHECKOUT. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    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. NO ADDITIONAL REPORTS HAVE BEEN RECEIVED FOR THIS DEVICE REGARDING THE REPORTED CONDITION. ROOT CAUSE: A ROOT CAUSE FOR THE CITRATE REACTION COULD NOT BE DEFINITIVELY DETERMINED. NO PROBLEMS WERE IDENTIFIED DURING CHECKOUT OF THE MACHINE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FOLLOW-UP WITH THE CUSTOMER DETERMINED THAT THE FLUIDS GIVEN TO THE PATIENT IN RESPONSE TO THE CITRATE REACTION WERE ORAL FLUIDS ONLY. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DONOR HAD A CITRATE REACTION ON THE TRIMA MACHINE DURING A DONATION. THE DONOR WAS CONSERVATIVELY TREATED AT THE DONATION SITE BY THE MEDICAL OFFICER WITH FLUIDS AND OBSERVATION, AND WAS RELEASED TO GO HOME AFTER BLOODS WERE CHECKED. PATIENT IDENTIFIER, AGE AND GENDER ARE NOT AVAILABLE AT THIS TIME. THIS WAS A SINGLE DOSE DONATION. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF FLUIDS GIVEN, THOUGH AT THIS TIME, THE EXTENT OF FLUIDS GIVEN IS NOT KNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DONOR HAD A CITRATE REACTION ON THE TRIMA MACHINE DURING A DONATION. THE DONOR REQUIRED TRANSPORT TO THE ACCIDENT & EMERGENCY DEPARTMENT VIA AMBULANCE, AND WAS DISCHARGED THE NEXT DAY. PATIENT IDENTIFIER, AGE AND GENDER ARE NOT AVAILABLE AT THIS TIME. THIS WAS A TRIPLE DOSE DONATION. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF OVERNIGHT HOSPITALIZATION. THE CUSTOMER REPORTED A DONOR HAD A CITRATE REACTION ON THE TRIMA MACHINE DURING A DONATION. THE DONOR WAS CONSERVATIVELY TREATED AT THE DONATION SITE BY THE MEDICAL OFFICER WITH FLUIDS AND OBSERVATION, AND WAS RELEASED TO GO HOME AFTER BLOODS WERE CHECKED. PATIENT IDENTIFIER, AGE AND GENDER ARE NOT AVAILABLE AT THIS TIME. THIS WAS A SINGLE DOSE DONATION. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF FLUIDS GIVEN, THOUGH AT THIS TIME, THE EXTENT OF FLUIDS GIVEN IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282754 TRIMA ACCEL TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM GKT TERUMO BCT 000000000917000000

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization