BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 6061424 · Received October 27, 2016

    Report

    Report Number
    2016493-2016-00815
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 12, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: BAXTER 250ML BAG OF 0.9% NACL INJECTION, NDC (B)(4), LOT Y012377, EXP AUG 2017; 8110; SPM SET; (2) 8100; PRI TUBING; THERAPY DATE (B)(6) 2016. ADDITIONAL MEDWATCH INFORMATION PROVIDED. CONCLUSION CODE: FIELD LEFT BLANK; NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER'S REPORT OF AN OVERINFUSION OF TPN AND UNREGULATED FLOW WAS NOT CONFIRMED. PHYSICAL INSPECTION REVEALED A BROKEN PLATEN AT THE UPPER HINGE POST. THERE WERE NO ANOMALIES OBSERVED WITH THE PRIMARY SET. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 10:00PM ON (B)(6) 2016 THE DEVICE WAS PROGRAMMED TO INFUSE TPN > 1.5KG AT A RATE OF 4.5ML/HR . AT 12:15AM ON (B)(6) 2016, THE DEVICE ALARMED FOR AIR IN LINE. THE INFUSION WAS RESTARTED. AT 12:16 AM, THE DEVICE AGAIN ALARMED FOR AIR IN LINE. AT 12:22 AM, THE DEVICE ALARMED FOR CHECK IV SET. THE DEVICE WAS THEN CHANNELED OFF, AND AT 12:34 AM WAS REMOVED FROM THE SYSTEM. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD IS 10.102ML. FUNCTIONAL TESTING FOUND THE DEVICE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THERE WERE NO LEAKS OBSERVED FROM THE SET. ALTHOUGH THE UNREGULATED FLOW WAS NOT CONFIRMED OR REPLICATED BY TESTING, THE LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED AS A BROKEN PLATEN POST AT THE TOP HINGE, WHICH CAN CAUSE INTERMITTENT UNREGULATED FLOW DEPENDING ON HOW THE PLATEN SITS WHEN THE DOOR IS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT 10PM ON (B)(6) 2016 170 ML TPN WAS HUNG AS A PRIMARY TO INFUSE AT 4.5 ML/HR OVER 24 HOURS. THE NURSE REPORTED THERE WERE NO ISSUES WITH LOADING THE SET OR CLOSING THE DOOR. ONE HOUR LATER THE PATIENT HAD DECREASED OXYGEN SATURATION LEVELS. THIS WAS CORRECTED VIA UNSPECIFIED MEANS. AT MIDNIGHT AIR WAS NOTED IN THE TUBING AND THE FLUID CONTAINER WAS EMPTY, WITH NO AIR IN LINE ALARM. A STAT GLUCOSE LEVEL WAS DRAWN WITH A RESULT OF 1200. THE PATIENT SLOWLY STABILIZED BACK TO THE PRE-EVENT BASELINE CONDITION. THE PUMP WAS REMOVED FROM THE PATIENT AFTER THE EVENT, AND TESTING BY THE NURSE WITH A 250 ML VTBI RESULTED IN A FREE FLOW CONDITION WITH NO ISSUES HAVING BEEN NOTED WHEN LOADING THE SET FOR THIS TEST. THE DEVICE WAS THEN SENT TO THE FACILITY BIOMED WHO NOTED DURING INSPECTION THAT THE PLATEN WAS CRACKED AT THE TOP HINGE, BUT THE DAMAGE WAS ONLY NOTICEABLE IF THE PLATEN WAS PUSHED.

    Description of Event or Problem · 1

    RECEIVED FROM THE FDA A COPY OF THE SUS VOLUNTARY EVENT REPORT WHICH STATES: "A (B)(6) GESTATION BABY WAS GIVEN 170 ML OF TPN IN APPROX 2 HOURS. THE PUMP WAS SET CORRECTLY AT 4.5ML HOUR, HOWEVER THE WHOLE VOLUME INFUSED INCORRECTLY. THE PUMP WAS REMOVED AND A TEST OF NS 250ML WAS RUN ON THE PUMP AT THE SAME RATE AND AGAIN IT INFUSED THE WHOLE VOLUME IN APPROX 45 MINUTES. THE NEONATOLOGIST WAS NOTIFIED AND APPROPRIATE WERE GIVEN. SEIZURE ACTIVITY WAS NOTED AND TREATED. BLOOD SUGAR WAS 1235 AND WAS ALSO APPROPRIATELY TREATED. THE PT WAS ON A JET VENTILATOR, HOWEVER AFTER REQUIRED MORE RESPIRATORY SUPPORT AND VASO-ACTIVE DRUGS WERE INCREASED AFTER THE INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713285 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRI TUBING, 8015, THERAPY DATE: