BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1983755 · Received February 4, 2011

    Report

    Report Number
    9616066-2011-00037
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 02/04/2011. (B)(4). SET WAS DISCARDED AT THE HOSPITAL. NO INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE PRIMARY IV SET (MODEL NUMBER UNKNOWN) WAS FOUND LEAKING FROM PIN PRICK SIZE HOLES THROUGHOUT A MAJORITY OF THE TUBING DISTAL TO THE PUMP. THE SET WAS DISCARDED BY THE HOSPITAL. NO PATIENT HARM REPORTED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK