BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023268 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00135
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND AN EVAL IS PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE BIOMED REPORTED AN OVER-INFUSION. EVENT DETAILS WERE REPORTED AS FOLLOWS: THE PT WAS RECEIVING CARDENE FOR BLOOD PRESSURE MANAGEMENT. A NEW BAG OF CARDENE WAS HUNG AT 0515, WITH VOLUME SET AT 150 ML AND RATE AT 62.5 ML OR 12.5 MG/HR. AT 0600, THE BAG WAS FOUND ALMOST COMPLETELY EMPTY AND THE PUMP VOLUME STATED 104 ML LEFT. THE RATE REMAINED UNCHANGED AT 12.5 MG/HR. THE PT REMAINED UNCHANGED HEMODYNAMICALLY WITH NO SIGNIFICANT DROP IN BLOOD PRESSURE. THE PUMP WAS CHANGED OUT AND THE CARDENE TUBING CHANGED. THERE WAS NO HARM TO THE PT AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER PT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84968 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ALARIS PCA MODULE ADMIN SET, MODEL# UNK, LOT# UNK| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PCA MODULE, SN (B)(4)| ALARIS PUMP MODULE ADMIN SET, MODEL# UNK, LOT# UNK| ALARIS PUMP MODULE, SN (B)(4)| ALARIS PC UNIT, SN (B)(4)