BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 6616291 · Received June 6, 2017

    Report

    Report Number
    9616066-2017-00867
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 24, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 500 ML B.BRAUN BAG NDC 0264-7800-10, LOT: J6L317, EXP: 03/19, 0.9% NACL INJECTION; 200 ML HOSPIRA BAG. NDC 0409-7075-26, LOT: 70-113-JT, EXP: 1 APR 2018, KCL, THERAPY DATE: (B)(6) 2017. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS NOT CONFIRMED HOWEVER A CHECK VALVE FAILURE IN THE PRIMARY SET WAS CONFIRMED. THE PCU EVENT LOG SHOWS THAT AT 10:11 AM ON (B)(6) 2017 THE PUMP MODULE WAS PROGRAMMED TO INFUSE A PRIMARY INFUSION OF IVF NO ADDITIVES AT A RATE OF 10 ML/HR, AND A SECONDARY INFUSION OF POTASSIUM CHLORIDE PERIPHERAL CONC 20MEQ IN 100 ML AT A RATE OF 50 ML/HR. AT 10:51 AM THE SECONDARY INFUSION RATE WAS DECREASED TO 25 ML/HR. AT 11:03 AM IT WAS CHANGED BACK TO 50 ML/HR. THE INFUSION WAS STOPPED WHEN THE DEVICE WAS CHANNELED OFF AT 11:43 AM. FUNCTIONAL TESTING FOUND THE DEVICE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THERE WERE NO LEAKS OBSERVED FROM THE SET. FUNCTIONAL TESTING CONFIRMED BACKFLOW FROM THE SECONDARY INTO THE PRIMARY INDICATING A FAULTY CHECK VALVE. HOWEVER, THE CHECK VALVE PASSED SUPPLIER TESTING AND NO PARTICULATES WERE FOUND ON THE MEMBRANE. THE ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED AS A BACKFLOW ISSUE DUE TO A FAULTY CHECK VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INFUSION OF 20 MEQ KCL IN 100 ML IVPB HUNG AT 1017 WAS PROGRAMED TO INFUSE AT 50 ML/H FOR 2 HOURS. THE CLINICIAN ENTERED PATIENT¿S ROOM AT 1045 WHEN THE PATIENT WAS COMPLAINING OF A SLIGHT BURNING AT IV SITE. THE CLINICIAN SLOWED THE INFUSION TO 25 ML/H, THEN NOTED KCL BAG WAS EMPTY. PROGRAM ON PUMP VERIFIED CORRECT, AND VTBI INDICATED 70 ML LEFT TO INFUSE FROM IVPB. IV SITE CHECKED, NO EVIDENCE OF INFILTRATION, POSITIVE BLOOD RETURN. INFUSION AND DEVICES WERE REMOVED FROM PATIENT. THERE WAS NO PATIENT HARM OR INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396720 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007

    Patients

    Seq Age Sex Outcome Treatment
    1