BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4011992 · Received July 9, 2014

    Report

    Report Number
    9616066-2014-00673
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 07/09/2014. (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED

    Description of Event or Problem · 1

    THE IV TUBING SPIKE SLIPPED OUT AND SOLUTION LEAKED OUT ONTO THE NURSES HAND PLUS ABOUT 10ML LEAKED ON THE FLOOR. THE NURSE IMMEDIATELY TURNED THE BAG OVER TO STOP THE SPILL AND REINSERTED THE SPIKE. THE CUSTOMER USES A B. BRAUN PVC-FREE BAG. NO PATIENT OR STAFF HARM WAS REPORTED. NO FURTHER PATIENT/EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402550 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN B-BRAUN IV BAG, MODEL/LOT UNK