BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T34 SYRINGE PUMP

    MDR report key: 5082813 · Received September 16, 2015

    Report

    Report Number
    3006967710-2015-00007
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Report Date
    August 19, 2015
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    PMA / PMN Number
    K080954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WE RECEIVED THE COMPLAINT DEVICE AND REVIEWED THE EVENT LOG. ACCORDING TO THE EVENT LOG, THE INFUSION WAS STARTED AT 08:38 ON (B)(6) JUST AS THE COMPLAINANT STATED. THE PUMP INFUSED AT THE BASAL RATE OF 0.42ML/HR. THE INFUSION CONTINUED UNTIL 12:31 (~4 HOURS LATER) WHEN THE INFUSION WAS MANUALLY STOPPED BY THE USER. THE INFUSION IS THEN INITIATED AND STOPPED MULTIPLE TIMES UNTIL THE PUMP IS FINALLY SHUT OFF AT 13:11. THE DEVICE IS NEVER TURNED BACK ON AND THE INFUSION IS NOT RESUMED ON (B)(6). WE ATTEMPTED TO REPRODUCE THE PATIENT'S EXPERIENCE BY RESTARTING THEIR INFUSION AND MONITORING THE DEVICE FOR THE DURATION OF THE ~24 HOUR INFUSION. WE STARTED THE INFUSION AT 11:21 ON (B)(6), AND THE INFUSION SUCCESSFULLY COMPLETED 23 HOURS AND 33 MINUTES LATER AT 10:54 ON (B)(6) JUST AS EXPECTED. THE PUMP OPERATED ACCORDING TO SPECIFICATION (1.1% OVER-INFUSION, WITHIN THE SPECIFICATION OF ±5%). THE DEVICE CORRECTLY IDENTIFIED THE SYRINGE SIZE AND MANUFACTURER AND THE VOLUME INFUSED WAS WITHIN PUMP SPECIFICATION (±5%). T34 SYRINGE PUMP OPERATOR'S MANUAL, 100-090SS, WAS REVIEWED AND FOUND TO BE ADEQUATE. ROOT CAUSE, "PATIENT TAMPERING," WILL BE ADDRESSED WITH A LETTER TO THE CUSTOMER. IT IS EVIDENT THE PATIENT TAMPERED WITH THE SYRINGE PUMP, AS RECORDED ON THE EVENT LOG. THE ROOT CAUSE OF THIS COMPLAINT IS PATIENT TAMPERING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PUMP OVER-INFUSED DURING PATIENT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614040 T34 SYRINGE PUMP T34 SYRINGE PUMP FRN CME AMERICA LLC 100-100OBSC

    Patients

    Seq Age Sex Outcome Treatment
    1