BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4214095 · Received August 6, 2014

    Report

    Report Number
    9616066-2014-00737
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 16, 2014
    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). THE AFFECTED PRODUCT AND DATA SET HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SUSPECTED BACK CHECK VALVE FAILURE WHEN METHYLPREDNISOLONE WAS SET TO INFUSE AS A SECONDARY MEDICATION. EVENT WAS WITNESSED BY THE CLINICIAN WHO IMMEDIATELY INTERVENED SO THAT NO HARM WAS DONE. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459104 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2414-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN (B)(4)| SECONDARY TUBING: MFR UNK, MODEL UNK, LOT UNK| ALARIS PCU: (B)(4)