BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3023183 · Received February 27, 2013

    Report

    Report Number
    2016493-2013-00120
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    July 1, 2012
    Report Date
    January 30, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    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). BIOMED'S FINDINGS: "NO HARDWARE FAILURE WAS FOUND THAT WOULD CONTRIBUTE TO AN OVER INFUSION. IT IS MY OPINION THAT THE PUMP MODULE REQUIRES RATE CALIBRATION AND RETESTING PRIOR TO RETURN TO SERVICE; AND THE BALANCE OF THE SYSTEM MAY BE RETURNED TO SERVICE WITH THE APPROVAL OF THE RISK MGR." THE REPORT OF AN OVER INFUSION COULD NOT BE CONFIRMED. ALTHOUGH REQUESTED, NO DEVICE OR EVENT LOGS HAVE BEEN RETURNED FOR THIS EVALUATION. 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 ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84565 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK:| ALARIS PUMP MODULE AMDINISTRATION SET:| MODEL/LOT: UNK