BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T34 SYRINGE PUMP

    MDR report key: 4995351 · Received August 12, 2015

    Report

    Report Number
    3006967710-2015-00006
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    July 15, 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 09:09 ON (B)(6) JUST AS THE COMPLAINANT STATED. THE CLINICIAN IMMEDIATELY INITIATED A DEMAND BOLUS OF 1ML AT A RATE OF 5ML/HR, AND THE PUMP THEN INFUSED AT THE BASAL RATE OF 0.25ML/HR. THE INFUSION CONTINUED UNTIL 13:16 (4 HOURS LATER) WHEN THE SYRINGE WAS MANUALLY REMOVED FROM THE DEVICE DURING OPERATION. AFTER REMOVING THE SYRINGE FROM THE DEVICE AT 13:16 ON (B)(6), THE PATIENT TURNED OFF THE PUMP, AND THE INFUSION WAS NOT RESUMED. THE EVENT LOG CONTRADICTS THE CUSTOMER REPORT THAT AN ENTIRE 10 ML SYRINGE WAS EMPTY AT 2100 (12 HOURS), AND THE PUMP TURNED OFF ON ITS OWN. WE ATTEMPTED TO REPRODUCE THE PATIENT'S EXPERIENCE BY RESTARTING THEIR INFUSION AND MONITORING THE DEVICE FOR THE DURATION OF THE 36 HOURS. WE STARTED THE INFUSION AT 15:40 ON (B)(6), AND THE INFUSION SUCCESSFULLY COMPLETED THIRTY-SIX HOURS LATER AT 03:53 ON (B)(6) JUST AS EXPECTED. THE PUMP OPERATED ACCORDING TO SPECIFICATION. VOLUME ACCURACY IS DETERMINED BY THE SYRINGE TABLES LOADED ON THE PUMP. CALIBRATION OF THE SYRINGE TABLES IS NOT REQUIRED UNLESS THE DIMENSIONS OF THE SYRINGES ARE CHANGED BY THE MANUFACTURER. THE DEVICE ACCURATELY IDENTIFIED THE SYRINGE SIZE AND MANUFACTURER, AND THE VOLUME INFUSED WAS ACCURATE WITH PUMP SPECIFICATION. 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. CME AMERICA HAS CONTACTED THE CUSTOMER AND REPORTED THE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AT 0900 PATIENT WAS STARTED ON PUMP VIA PICC. ADMINISTERED 5MG (1 ML) LOADING DOSE FOLLOWED BY 0.25 ML/HR BASAL RATE. PATIENT REPORTS THE ENTIRE 10 ML SYRINGE WAS EMPTY AT 2100 (12 HRS). PUMP TURNED OFF PUMP AND DID NOT INFUSE ANY MORE. PATIENT REPORTED FEELING OF ANXIETY WHEN DISCOVERY MADE. ON (B)(6) 2015 HOMECARE NURSE VISITED PATIENT. ASSESSMENT: PATIENT ALERT AND RESPONSIVE, VITAL SIGNS STABLE, BP 82/52, PULSE 100 AND TEMPERATURE 98.6. DRESSING CLEAN AND DRY. PATIENT REPORTS SIGNS AND SYMPTOMS IMPROVED FROM PREVIOUS NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529499 T34 SYRINGE PUMP T34 SYRINGE PUMP FRN CME AMERICA LLC 100-100POBSC

    Patients

    Seq Age Sex Outcome Treatment
    1