BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2851493 · Received November 7, 2012

    Report

    Report Number
    9616066-2012-00777
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 18, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER AS THE SET WAS DISCARDED. THE CUSTOMER REPORT OF SET DISCONNECTED FROM MICROCLAVE VALVE AND LEAKED COULD NOT BE CONFIRMED DUE TO PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE ALARIS PUMP MODULE ADMINISTRATION SET SPONTANEOUSLY DISCONNECTING FROM THE ICU MEDICAL MICROCLAVE VALVE ON A CENTRAL LINE THAT HAS RESULTED IN LEAKAGE. STATED THE DISCONNECTION OCCURS DURING VARIOUS DIFFERENT INFUSIONS (NOT CHEMO) ON LONG TERM PATIENTS. THE DISCONNECTION HAS NOT BEEN RELATED TO THE PATIENT'S ACTIVITY LEVEL. NO PATIENT HARM REPORTED. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ICU MEDICAL MICROCLAVE VALVE: MODEL/LOT UNKNOWN