BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSYSTEM III INFUSION PUMP

    MDR report key: 3833382 · Received May 16, 2014

    Report

    Report Number
    2016493-2014-00249
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K933545
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WITH FAILURE INVESTIGATION RESULTS WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN "ERROR 22" OCCURRED DURING AN INOTROPE INFUSION FOR A PATIENT IN THE CARDIOVASCULAR ICU. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. THE PATIENT WAS PUT IN TRENDELENBURG POSITION AND RIPS WERE INCREASED TO BRING THE BLOOD PRESSURE BACK UP. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293489 MEDSYSTEM III INFUSION PUMP FRN CAREFUSION CORPORATION 2865 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention