BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3925345 · Received July 2, 2014

    Report

    Report Number
    2016493-2014-00300
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CRITICALLY ILL PATIENT "ON MULTIPLE DRIPS" DROPPED SYSTOLIC BLOOD PRESSURE TO 50MMHG BECAUSE THE INFUSION STOPPED WHILE MOVING FROM GURNEY TO CT TABLE. THE NURSE STATED THE LINES RECEIVED SOME TENSION ON THEM WITH THE MOVE, AND THAT MAY HAVE POSSIBLY CAUSED THE INFUSION TO STOP. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385386 ALARIS PC UNIT INFUSION SYSTEM UNIT FRN CAREFUSION CORPORATION 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE TUBING: MODEL/LOT UNK| ALARIS PUMP MODULE: SN UNK