BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3940557 · Received April 18, 2014

    Report

    Report Number
    9616066-2014-00402
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 7, 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

    MANUFACTURER'S REPORT DATE: (B)(4) 2014. (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. NO PRODUCT WILL BE RETURNED PER CUSTOMER, BECAUSE IT WAS DISCARDED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    ICU NURSE REPORTED THAT AN ANTIBIOTIC HUNG AS A SECONDARY APPEARED TO INFUSE QUICKER THAN INTENDED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238506 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| THERAPY DATE: