BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4230916 · Received October 15, 2014

    Report

    Report Number
    2016493-2014-00485
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 23, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERINFUSION OF ARGATROBAN, INDICATING IT "WAS NOT CALCULATED CORRECTLY." ARGATROBAN 125 MG/125ML WAS SET UP AS A PRIMARY IN THE MED/SURG/ONC PROFILE TO INFUSE AT 241 MCG/MIN (2MCG/KG/MIN). THE USER NOTICED THE BAG WAS NEEDING TO BE CHANGING MORE FREQUENTLY THAN EXPECTED. THERE WAS NO REPORT OF HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652498 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ALARIS PRIMARY TUBING: MODEL/LOT UNK| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PCU: SN (B)(4)