BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3251805 · Received July 17, 2013

    Report

    Report Number
    2016493-2013-00319
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 1, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATES THAT THE DEVICE LOGS AND DATASET WILL BE SUBMITTED BUT THE LOGS AND DATA SET HAVE NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE LOGS/DATASET OR DEVICE BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    VIRTUALLY NO DETAILS ARE CURRENTLY AVAILABLE; THE CUSTOMER ONLY PROVIDED THE ORIGINAL INFO THAT STATES "PLEASE BE ADVISED THAT LAST EVENING A PT RECEIVED A BOLUS OF HEPARIN. GUARDRAILS WERE SET. IT APPEARS IT MAY HAVE BEEN MECHANICAL. THE PUMP HAS BEEN SEQUESTERED." NO REPORT OF PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331681 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK