BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 1890822 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00024
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    January 30, 2009
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RISK ANALYSIS: THE TRIMA IS DESIGNED TO PROTECT AN OPERATOR IF A SHORT OCCURS WITHIN THE MACHINE BY CONNECTING TO THE EARTH-GROUND CONNECTION IN A FACILITY. IN THIS CIRCUMSTANCE THERE WAS AN ISSUE THAT WAS INTERRUPTING THIS EARTH-GROUND CONNECTION AT THE FACILITY. THE SHOCK RECEIVED BY THE NURSE AT THIS FACILITY DID NOT CAUSE SERIOUS INJURY THAT WOULD RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION, OR, PERMANENT DAMAGE TO A BODY STRUCTURE, NOR WOULD IT NECESSITATE MEDICAL OR SURGICAL INTERVENTION BY A HEALTH CARE PROFESSIONAL TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION, OR, PERMANENT DAMAGE TO A BODY STRUCTURE. FIELD DIAGNOSTIC/CORRECTION: THE SERVICE REP CHECKED THE EQUIPMENT AND FOUND NO ISSUES. HE DID, HOWEVER, FIND ISSUE WITH THE ELECTRICAL OUTLETS AT THE CUSTOMER SITE. SOME OF THE PLUGS WERE MISSING EARTH CONNECTION, CAUSING APPROXIMATELY 100V OF ELECTRICITY BETWEEN THE MACHINE GROUND AND REAL EARTH GROUND. THIS IS AN ISSUE WITH THE CUSTOMER'S FACILITY. INVESTIGATION: EXTENT OF THE INJURY TO THE NURSE WAS A LOW LEVEL ELECTRICAL SHOCK. NO MEDICAL INTERVENTION WAS PERFORMED. ROOT CAUSE: CUSTOMER FACILITY ISSUE. CORRECTIVE/PREVENTIVE ACTION: THE CUSTOMER IS AWARE OF THE ELECTRICAL ISSUE AT THEIR FACILITY AND HAVE WORKED TO DISCOVER MITIGATIONS FOR THE PROBLEM. THEY DO NOT ALLEGE THAT THE TRIMA MACHINE IN ANY WAY WAS RESPONSIBLE FOR THE ISSUES OR THE SHOCKS TO THE NURSE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. CUSTOMER REPORTED THAT THEY WERE RECEIVING ELECTRICAL DISCHARGE SHOCKS WHEN TOUCHING THE IV POLE ON THEIR TRIMA AND FUSES IN THE CUSTOMER'S ELECTRICAL ROOM WENT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention