BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 7503851 · Received May 10, 2018

    Report

    Report Number
    9616066-2018-00600
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    April 5, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF A BROKEN SPIKE WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT NEARLY THE ENTIRE DRIP CHAMBER SPIKE WAS BROKEN OFF AND REMAINED STUCK INSIDE ONE OF THE IV BAG SPIKE PORTS. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TUBING SPIKE BROKE OFF INTO THE NORMAL SALINE IV BAG AND THE BAG FELL ONTO THE FLOOR WHILE THE PATIENT WAS IN THE BATHROOM. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 1000ML B.BRAUN BAG NDC: 0265-7800-09, LOT NUMBER: J8A779, EXP: 07/2020, 0.9% SODIUM CHLORIDE; THERAPY DATE UNKNOWN. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBING SPIKE BROKE OFF INTO THE NORMAL SALINE IV BAG AND THE BAG FELL ONTO THE FLOOR WHILE THE PATIENT WAS IN THE BATHROOM. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346218 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2426-0500

    Patients

    Seq Age Sex Outcome Treatment
    1