BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3134005 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00319
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE PATIENT WENT TO THE RESTROOM, THE IV SET CAME APART AT THE PUMP SEGMENT. THE CUSTOMER STATED THAT VANCOMYCIN WAS INFUSING AT THE TIME OF THE SEPARATION. THERE WAS NO REPORT OF PATIENT HARM. MEDICAL INTERVENTION WAS NOT REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191059 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN