BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 8354420 · Received February 20, 2019

    Report

    Report Number
    2016493-2019-00176
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    November 21, 2018
    Report Date
    January 24, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 100ML FRESENIUS KABI BOTTLE, NDC (B)(4), LOT 16ME0983, EXP 04 2020, DIPRIVAN PROPOFOL INJECTION. THE CUSTOMER¿S REPORT OF AN OVERINFUSION AND UNACCOUNTED PROPOFOL WAS NOT NEITHER CONFIRMED NOR REPLICATED. THE PCU EVENT LOG CONTAINED NO OBVIOUS PROGRAMMING ERRORS THAT WOULD RESULT IN THE REPORTED EVENT. FUNCTIONAL TESTING PERFORMED FOUND THE PUMP MODULE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THERE WERE NO ANOMALIES OBSERVED WITH THE RETURNED PRIMARY SET AND THERE WERE NO LEAKS OBSERVED FROM THE SET. THE STARTING/ENDING VOLUME OF THE FLUID CONTAINER CANNOT BE DETERMINED THROUGH DEVICE LOGS. THE ROOT CAUSE OF THE REPORTED OVERINFUSION AND UNACCOUNTED PROPOFOL WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEW BOTTLE OF PROPOFOL (1000MG IN 100ML) WAS HUNG AT 0500 INFUSING AT 20MCG/KG/MIN (APPROXIMATELY 13ML/HOUR). AT 0630, IT WAS NOTED THAT THE 100ML BOTTLE WAS EMPTY. THE NURSE CHECKED THE DEVICE TO ASSESS THE PROGRAMMING, AND IT WAS PROGRAMMED CORRECTLY. THE PATIENT WAS ALERT, ABLE TO FOLLOW ALL COMMANDS, AND DID NOT HAVE ANY CHANGES IN VITAL SIGNS. THE NURSE RESUMED THE MEDICATION AS INSTRUCTED. THE LOGS WERE REVIEWED ON NOVEMBER 26, 2018; THE MEDICATION WAS STARTED ON (B)(6) 2018 AT 05:21:12 AND THERE WAS AN AIR IN LINE ALARM AT 06:21:00, WHICH WAS PRESUMABLY DUE TO THE BOTTLE BEING EMPTY. THE CUSTOMER WAS UNABLE TO EXPLAIN HOW THE BOTTLE BECAME EMPTY IN ONE HOUR. THE PATIENT'S BLOOD PRESSURE WAS UNCHANGED AT THE END OF THE REPORTED OVER-INFUSION. THERE WAS NO EVIDENCE OF MEDICATION HAVING LEAKED FROM THE BOTTLE OR IV SET. WATER WAS ADDED TO THE MEDICATION BOTTLE TO CHECK FOR A FREE-FLOW OR PARTIAL FREE-FLOW SITUATION, AND NONE WAS FOUND. BIOMED TESTED THE RATE ACCURACY OF THE PUMP MODULE, AND THE FINDINGS WERE WITHIN NORMAL LIMITS. THE CUSTOMER REPORTS THERE WAS A SECOND PCU IN USE AT THE TIME OF THE EVENT, PRESUMABLY WITH ADDITIONAL PUMP MODULES, BUT THEY WERE NOT ABLE TO BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149822 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR