BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3220772 · Received June 26, 2013

    Report

    Report Number
    2016493-2013-00291
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE REC'D FOR EVAL.

    Description of Event or Problem · 1

    WITHIN LESS THAN A MIN OF STARTING A NORADRENALINE INFUSION AT 3ML/H THE CUSTOMER EXPERIENCED A "CHANNEL BLOCKED PUMP ERROR." THEY REPORTED THAT FOLLOWING THE INITIAL ALARM, THEY "CLAMPED LINES AND UNLOADED FROM MODULE, RELOADED MODULE AND ATTEMPTED TO RECOMMENCE, SAME MESSAGE, UNLOADED AGAIN REMOVED MODULE AND PLACED ON OTHER SIDE OF PUMP BRAIN (ATTEMPTING TO 'RESET' MODULE) HOWEVER SAME MESSAGE DISPLAYED. REMOVED MODULE BUT NOT PUMP BRAIN." THE REPORT INDICATES THAT THE PT'S BLOOD PRESSURE INCREASED TO 220 SYSTOLIC BEFORE SLOWLY REDUCING AND THAT THE PT COMPLAINED OF CHEST PAIN/TIGHTNESS IN THROAT. ACCORDING TO THE FEEDBACK, THE "NURSE DID REVIEW HISTORY AND NOTED THAT 1.?ML OF A VTBI OF 3MLS HAD BEEN INFUSED IN THAT INITIAL 1 MIN OF PUMP RUNNING." NO ADD'L PT OR EVENT INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291673 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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