BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3940542 · Received April 18, 2014

    Report

    Report Number
    2016493-2014-00211
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE REC'D FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PATIENT WAS EN ROUTE TO HIS ROOM FROM RADIOLOGY. WITHIN SECONDS AFTER EXITING THE ELEVATOR, THE PUMP MODULE STARTED ALARMING FOR A COMMUNICATION ERROR. A SECONDARY OF ANTIBIOTICS WAS INFUSING AT THE TIME OF THE ALARM. THE PUMP MODULE WAS REMOVED FROM THE SYSTEM AND INSPECTED. THE CUSTOMER STATED GREEN CORROSION WAS PRESENT ON THE TOP AND BOTTOM OF THE PINS OF THE MALE IUI CONNECTOR. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238503 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL/LOT # UNK| ALARIS PC UNIT SN UNK| ALARIS PUMP MODULE ADMINISTRATION SET,