BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4092413 · Received September 5, 2014

    Report

    Report Number
    9616066-2014-00922
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Report Date
    August 22, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD BUBBLING OR BALLOONING AT THE PUMP SEGMENT PORTION OF THE TUBING. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. NO ADD'L PT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545799 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP 11404930 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK