BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2221920 · Received August 17, 2011

    Report

    Report Number
    2016493-2011-00469
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 27, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE AND LOGS HAVE NOT BEEN REC'D. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE AND LOGS BE REC'D FOR EVAL.

    Description of Event or Problem · 1

    BIOMED CALLED TO REPORT THAT A DRUG WAS INFUSING TOO FAST. THE DRUG INFUSING WAS ZOSYN AND WAS TO BE INFUSED IN 4 HRS BUT COMPLETED IN 1 HR. THE CUSTOMER REQUESTED AN EVENT LOG REVIEW. THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMINISTRATION SET:| MODEL AND LOT # UNKNOWN