BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2052473 · Received March 15, 2011

    Report

    Report Number
    2016493-2011-00229
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    October 8, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S COMPLAINT OF A CHANNEL DISCONNECT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION ALTHOUGH REQUESTED ON MULTIPLE OCCASIONS (4 ATTEMPTS VIA PHONE AND E-MAIL AND 1 ATTEMPT DURING CUSTOMER SITE VISIT). THE CAUSE OF THE CUSTOMER'S CHANNEL DISCONNECT IS UNKNOWN. UPON FURTHER EVALUATION, WE HAVE DETERMINED THIS TO BE REPORTABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CHANNEL DISCONNECT OCCURRED ON A PATIENT WITH A SALINE INFUSION. THE CUSTOMER ALSO REQUESTED ANALYSIS OF ANY FLUID RESIDUE FOUND ON THE IUI CONNECTOR. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT: SERIAL NUMBER (B)(4)