BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4161001 · Received July 23, 2014

    Report

    Report Number
    9616066-2014-00687
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    CUSTOMER REPORTED IV FLUID LEAKING FROM A CUT IN THE SILICONE SEGMENT NEAR THE UPPER FITMENT DURING INFUSION. NO PT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431033 ALARIS PUMP MODULE ADMINISTRATION SET IV SET FPA CAREFUSION CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT AND PUMP MODULE, SNS# UNK