BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1945838 · Received December 22, 2010

    Report

    Report Number
    9616066-2010-00376
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 22, 2010
    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

    MFR'S REPORT DATE: 12/22/2010. (B)(4). NO PRODUCT WAS RETURNED FOR EVAL, CUSTOMER STATED THE SET WAS DISCARDED AT THE FACILITY. THE LOT NUMBER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PT'S IV TUBING SPONTANEOUSLY DISCONNECTED DURING AN INFUSION OF IV FLUIDS. THE TUBING WAS REPLACED WITHOUT INCIDENT. NO PT HARM REPORTED. NO ADDITIONAL EVENT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA ALARIS PUMP MODULE: SERIAL NUMBER UNK| ALARIS PC UNIT: SERIAL NUMBER UNK