BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6341650 · Received February 17, 2017

    Report

    Report Number
    2016493-2017-00139
    Event Type
    Death
    Date Received
    February 17, 2017
    Date of Event
    January 22, 2017
    Report Date
    January 25, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT BAXTER TRANSFER SET IS MODEL 1C8592, LOT GR336024; THERAPY DATE (B)(6) 2017. ADDITIONAL MEDWATCH INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BAXTER BIFURCATED IV SET; EXACTAMIX BAXTER BAG, MODEL # UNK, 500 ML, EVA CONTAINER, LOT # 1190335; THERAPY DATE 01/22/2017. ALTHOUGH REQUESTED, THE AFFECTED DEVICES HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED OVERINFUSION OF TPN COULD NOT BE CONFIRMED. BASED ON THE LOG REVIEW THE DEVICES IN USE WERE FOUND TO BE PROGRAMMED AS REPORTED. THE LOG RECORDED A SAFETY CLAMP OPEN ALARM LASTING 29 SECONDS, BUT IT COULD NOT BE DETERMINED IF THIS CONTRIBUTED TO THE REPORTED OVERINFUSION. NO TESTING WAS PERFORMED ON THE DEVICES. THE DEVICES WERE INSPECTED AT THE CUSTOMER SITE BY (B)(4) EMPLOYEES AND BOTH PUMP MODULES WERE FOUND TO HAVE 3RD PARTY DOOR LATCH/SEAR ASSEMBLIES. PRIOR INVESTIGATIONS OF 3RD PARTY DOOR LATCH/SEAR ASSEMBLIES FOUND THAT DURING THE ADMINISTRATION SET REMOVAL, THE SET SAFETY CLAMP CAN FAIL TO ACTIVATE AND ENGAGE WITH THE SEAR WHEN THE DOOR LATCH IS OPENED. AS A RESULT, A SAFETY CLAMP OPEN/CLOSE DOOR ALARM WILL BE TRIGGERED IF THE DEVICE IS ON. IF THE DEVICE IS OFF, NO ALARM WILL OCCUR. IF THE ROLLER CLAMP IS NOT CLOSED BEFORE OPENING THE DOOR, PER THE DIRECTIONS FOR USE, AND THE SEAR FAILS TO ENGAGE WITH THE SAFETY CLAMP, THERE IS A POTENTIAL THAT AN OVER-INFUSION COULD OCCUR DUE TO UNREGULATED FLOW (FREE FLOW) FOLLOWED BY A SAFETY CLAMP OPEN/CLOSE DOOR ALARM IF THE DEVICE IS ON. THE ROOT CAUSE OF THE OVERINFUSION OF TPN COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE SUS VOLUNTARY EVENT REPORT WHICH STATES: "TPN BAG NOTED TO BE EMPTY WITH IVF INFUSING AT CORRECT RATE THROUGH THE IV PUMP. INFANT RECEIVED 24 HOUR VOLUME IN 12 HOUR PERIOD. MD NOTIFIED. TO BEDSIDE. SUSPECTED SEIZURES. THIS REPORT LISTS CAREFUSION SMARTSITE LOW SORBING INFUSION SET 16127819 12/29/019, (B)(4). CONCOMITANT PRODUCTS: BAXTER BIFURCATED ADD ON TRANSFER SET, LOT (10) GR336024 WAS ALSO USED, HOWEVER DO NOT, FEEL AT THIS TIME THAT IT POTENTIALLY CONTRIBUTED TO THE EVENT."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BAG-BASED TPN WAS EXPECTED TO INFUSE AT 2 ML/HOUR OVER 24 HOURS, AND INFUSED FASTER THAN EXPECTED IN 12 HOURS ON AN UNSTABLE CRITICALLY ILL PATIENT. TPN FROM THE SAME BAG WAS ALSO INFUSING VIA A BIFURCATED SET THROUGH ANOTHER PUMP MODULE AT A RATE OF 1.6 ML/HR FOR A TOTAL TPN INFUSION RATE OF 3.6 ML/HR. THE VTBI WAS LABELED ON THE BAG AS 86.4 ML PLUS 100 ML OVERFILL FOR A TOTAL COMPOUNDED VOLUME OF 186.4 ML. PRIOR TO THE EVENT, AIR IN LINE AND OCCLUSION ALARMS WERE OBSERVED; DURING TROUBLESHOOTING OF THE ALARMS THE CLINICIANS WERE MANIPULATING THE SAFETY CLAMP INCLUDING ¿SLIDING THE WHITE PART BACK AND FORTH AND RELOADING OF THE SET WHILE CONNECTED TO THE PATIENT.¿ LABS WERE DRAWN AND RESULTS WERE ELEVATED INCLUDING BLOOD GLUCOSE. A HEAD ULTRASOUND SHOWED WORSENING OF A BRAIN HEMORRHAGE THAT WAS PRESENT ON ADMISSION. THE PATIENT EXPIRED SEVERAL DAYS LATER, HOWEVER IT IS NOT KNOWN IF THE EVENT CONTRIBUTED TO THE PATIENT¿S DEATH.

    Description of Event or Problem · 1

    THE TPN BAG WAS CHANGED ON (B)(6) 2017 AT 5 PM. THE VTBI WAS PROGRAMMED IN 4 HOUR INCREMENTS WITH HOURLY INFUSION SITE ASSESSMENT. AFTER THE INFUSION WAS DISCONTINUED, AN INCREASE IN APNEA/BRADYCARDIA EVENTS OCCURRED WITH SUSPECTED SEIZURE ACTIVITY. LAB WORK WAS DRAWN WITH BLOOD GLUCOSE RESULTS IN EXCESS OF 600. LIFE SUSTAINING TREATMENTS WERE ELECTIVELY WITHDRAWN AND THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121981 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Death 8100, 8015,(B)(4), 8110,