BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2060902 · Received April 8, 2011

    Report

    Report Number
    9616066-2011-00112
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CAREFUSION CORPORATION
    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

    MFR'S REPORT DATE: 04/08/2011. INTERNAL (B)(4). AN INVESTIGATION COULD NOT BE PERFORMED. REPORTER INDICATED ON MEDWATCH THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. THE CAUSE OF REPORTED LEAK IS UNK.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH REPORTED "NURSE ENTERED ROOM TO COMPLETE BEDSIDE REPORT; MOM STATED THAT TUBING WAS DISCONNECTED FROM PT. SPONTANEOUS DISCONNECT OF TUBING AND IV TUBING WAS DANGLING. TUBING AND FLUID WERE REMOVED AND NEW IV FLUID AND TUBING STRUNG. PHYSICIAN'S WERE NOTIFIED THAT MEDICATION INFUSION BECAME DISCONNECTED." NO PT HARM WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO ALARIS PC UNIT: SERIAL # UNK| ALARIS PUMP MODULE: SERIAL # UNK