BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3807987 · Received February 7, 2014

    Report

    Report Number
    9616066-2014-00119
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Report Date
    November 13, 2013
    Manufacturer
    CAREUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 02/07/2014. INTERNAL FILE NO: (B)(4). THE CUSTOMER'S REPORT OF LEAKING WAS CONFIRMED. VISUAL INSPECTION OF THE SET REVEALED A TEAR IN THE SILICONE SEGMENT MEASURING APPROX 0.0526 INCHES. FUNCTIONAL TESTING WAS PERFORMED; A LEAK FROM THE TEAR WAS CONFIRMED. THE CAUSE OF THE LEAK WAS DUE TO THE TEAR IN THE SILICONE SEGMENT. THE ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING PRIMING, THE SET LEAKED FROM THE LOWER FITMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81135 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREUSION CORP 2430-0500 13066005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA