BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023267 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00118
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BIOMED'S FINDINGS: "NO HARDWARE FAILURE WAS FOUND THAT WOULD CONTRIBUTE TO AN OVER-INFUSION. IN ADDITION, THE EVENT LOG FOR THE PUMP IN QUESTION SHOWS THAT WITH THE EXCEPTION OF SOME LOST INFUSION TIME DUE TO ALARMS, THE PUMP INFUSED AT 67ML/HR FOR THE ENTIRE PERIOD IN QUESTION WITH A TOTAL VOLUME INFUSED OF ABOUT 276ML FOR THE PERIOD FROM 06:47 TO 11:15. IT IS MY OPINION THAT THE SYSTEM MAY BE RETURNED TO SERVICE." THE REPORT OF AN OVER-INFUSION COULD NOT BE CONFIRMED. ALTHOUGH REQUESTED, NO DEVICE OR EVENT LOGS HAVE BEEN RETURNED FOR EVAL. THE ROOT CAUSE OF THIS REPORT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    DURING A CONFERENCE CALL, THE CUSTOMER REPORTED A POSSIBLE OVER-INFUSION EVENT. ALTHOUGH THE REPORT DOES NOT CONTAIN ANY PT EVENT DETAILS, IT IS ASSUMED THAT THE EVENT WAS FOR AN OVER-INFUSION. THE INVESTIGATION FINDINGS PROVIDED CAME FROM A THIRD PARTY BIOMED'S REPORT. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84756 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

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