BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMIN SET

    MDR report key: 3904970 · Received June 4, 2014

    Report

    Report Number
    9616066-2014-00510
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CAREFUSION 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FLUID LEAKED FROM THE TUBING ABOVE THE UPPER FITMENT. . THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327912 ALARIS PUMP MODULE ADMIN SET IV INFUSION SET FPA CAREFUSION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT & PUMP: MODULE SNS UNK. TEVADAPTOR,| SPIKE PORT, EXT SET/LUER LOCK ADAPTOR,| MODEL/LOT UNK