BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7176569 · Received January 9, 2018

    Report

    Report Number
    9616066-2018-00027
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    November 13, 2017
    Report Date
    November 14, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML BAXTER BAG LOT # Y250092, EXP. (B)(6)/ RECEIVED 0.9% SODIUM CHLORIDE INJECTION USP. 250ML BAXTER BAG LOT # Y245886, EXP. (B)(6) / RECEIVED 0.9% SODIUM CHLORIDE INJECTION USP. CONCLUSION CODE FIELD LEFT BLANK: NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF A PERCEIVED OVERINFUSION WAS CONFIRMED, DUE TO A CHECK VALVE FAILURE THAT ALLOWED FLUID TO BACKFLOW FROM THE SECONDARY CONTAINER INTO THE PRIMARY CONTAINER. FUNCTIONAL TESTING FOUND THE PUMP MODULE WAS DELIVERING FLUID WITHIN SPECIFICATION. TESTING CONFIRMED BACKFLOW FROM THE SECONDARY CONTAINER INTO THE PRIMARY CONTAINER INDICATING A FAULTY CHECK VALVE IN THE PRIMARY INFUSION SET. THE ROOT CAUSE OF THE PERCEIVED OVERINFUSION WAS A FAULTY CHECK VALVE. THE CAUSE OF THE FAULTY CHECK VALVE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SECONDARY INFUSION OF 250 ML OF VANCOMYCIN (1000MG) WAS PROGRAMMED TO INFUSE AT 130ML/HR (TOTAL VOLUME 285) FOR 2 HOURS HOWEVER AFTER 1 HOUR THE BAG WAS EMPTY. THE SECONDARY SOLUTION WAS PIGGY BACKED TO A PRIMARY SOLUTION OF 1000ML OF SALINE. THE PUMP STATED 129ML INFUSED WHEN THE 250ML BAG WAS NOTED TO BE EMPTY. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18058 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 11171447

    Patients

    Seq Age Sex Outcome Treatment
    1