BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1935503 · Received December 15, 2010

    Report

    Report Number
    9616066-2010-00370
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE SAMPLE WAS DISCARDED AT THE HOSP. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SET CAME APART IN THE ONCOLOGY UNIT AND TOTALLY SEPARATED DURING TRANSPORT. LOCATION OF THE SEPARATION IS UNK. THE EVENT OCCURRED DURING A PRIMARY INFUSION. NO PT HARM RESULTED. THE CUSTOMER STATES THE SET WAS DISCARDED. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK