BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3252591 · Received July 15, 2013

    Report

    Report Number
    2016493-2013-00310
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION. DOCTOR'S ORDERS WERE BENDAMUSTINE 170 MG IN NS 500 ML TO INFUSE OVER 30 MINUTES. THE BENDAMUSTINE PRIMARY INFUSION RATE 999 ML/HR AND VTBI 500 ML. IT WAS CONNECTED TO ITS OWN PICC LINE PORT. AT 1245 THE DEVICE WAS ALARMING KVO AND THE INFUSION BAG WAS STILL FULL AND THE VOLUME INFUSED READ 500 ML. CUSTOMER REQUESTED AN EVENT LOG REVIEW FROM 1200-1300 ON (B)(6) 2013 TO CHECK FOR KEYSTROKES, ALARMS, AND THE TOTAL VOLUME INFUSED SINCE THE DEVICE SAYS THE VOLUME WAS INFUSED BUT THE IV BAG WAS STILL FULL. A D5 + SODIUM BICARBONATE CONTINUOUS INFUSION 25 ML/HR WAS INFUSING ON CHANNEL B AT THE TIME OF THE EVENT. THE IVF INFUSION WAS ALSO CONNECTED TO ITS OWN PICC PORT. THERE WAS NO PT HARM. MEDICAL INTERVENTION WAS NOT REQUIRED. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327559 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK| PICC LINE: MFR/MODEL/LOT# UNK| ALARIS PC UNIT, SN (B)(4)