BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SE DUAL CHANNEL INFUSION PUMP

    MDR report key: 3110508 · Received April 24, 2013

    Report

    Report Number
    2016493-2013-00201
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 4, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH STATES "EVENT DESC: ARGATROBAN INFUSION (NEW BAG) WAS HUNG BY NURSE AT APPROXIMATELY 0300 AT A RATE OF 8.77 MCG/KG/MIN (EQUATING TO 30.5 ML/HR), AS PER ORDER. ORDER AND PUMP SETTINGS WERE VERIFIED BY SECOND NURSE. AT APPROXIMATELY 0400 THE PUMP WAS HEARD BEEPING; THE PUMP WAS CHECKED AND BAG FOUND TO BE EMPTY. AFTER THE BOLUS OF ARGATROBAN THE PATIENT WAS TRANSFERRED TO MICU FOR OBSERVATION (FOR BLEEDING), BUT REMAINED STABLE. THE PATIENT HAD BEEN DISCHARGED. CLINICAL ENGINEERING HAS BEEN ABLE TO FIND NOTHING WRONG WITH THE INFUSION PUMP." RELEVANT TESTS/LAB DATA CONTAINS A FEW LINES FROM AN EVENT LOG DATED (B)(6) 2013 FROM 04:04 TO 04:13 AND STATES "DOWNLOADED PUMP EVENT LOG ON (B)(6) 2013: LOG INDICATES THAT VOLUME INFUSED WAS NOT CLEARED PRIOR TO THE PROGRAMMING OF CHANNEL A TO INFUSE ARGATROBAN AT 03:04. THE VOLUME INFUSED FROM 03:04 TO 3:44 IS 20.6 ML, WHICH EQUATES TO A RATE OF 30.9 ML/HR. THIS MATCHES THE PROGRAMMED RATE OF 30.5 ML/HR. ACCORDING TO THE LOG, THE PUMP INFUSED PROPERLY." NO FURTHER EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177524 ALARIS SE DUAL CHANNEL INFUSION PUMP FRN CAREFUSION CORP. 7230 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ALARIS SE PUMP ADMINISTRATION SET, MODEL/LOT UNK