BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3940554 · Received April 18, 2014

    Report

    Report Number
    9616066-2014-00434
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IN THE ICU, A NURSE STARTED A SECONDARY INFUSION OF POTASSIUM AT 100 ML/HR, VTBI OF 100 MLS. THE NURSE HEARD THE PUMP MOTOR RUNNING FAST AND SAW THAT THE POTASSIUM WAS INFUSING RAPIDLY. THE NURSE IMMEDIATELY STOPPED THE INFUSION. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238497 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| SECONDARY TUBING: MFR/MODEL/LOT UNK| PUMP MODULES: SN'S (B)(4)| THERAPY DATE| THERAPY DATE