BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023249 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00130
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE OVER-INFUSION OF PROPOFOL. THE MEDICATION BOTTLE WAS EMPTY AFTER 5 HOURS AND SHOULD HAVE LASTED ALL DAY. A MILKY WHITE FLUID WAS NOTED ON THE PUMP AND THE FLOOR SO THE BIOMED SUSPECTS A TUBING LEAK. IT IS NOT KNOWN WHAT HAPPENED TO THE TUBING. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION. THE PT WAS READY TO BE TRANSFERRED OUT OF THE ICU. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84961 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK THERAPY DATE:| ALARIS PUMP MODULE ADMIN SET, MODEL UNK, LOT UNK| ALARIS PC UNIT, SN (B)(4)