BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3925359 · Received July 2, 2014

    Report

    Report Number
    2016493-2014-00341
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. REFERENCE ASSOCIATED MFR REPORTS: 2016493-2014-00342, 2016493-2014-00308. LOG ANALYSIS SHOWED THAT DURING THE COURSE OF AN INFUSION THAT STARTED ON (B)(6) 2014, AT 1:39 AM AND ENDED ON (B)(6) 2014 AND 8:20 PM, 9 CHANNEL DISCONNECT EVENTS OCCURRED ON THIS DEVICE. THE RESULTS OF TESTING AND INSPECTION OF THE PCU SN (B)(4) AND PUMP MODULES (B)(4) SUGGEST THE ROOT CAUSE OF THE CUSTOMER'S REPORTED ISSUE TO BE RELATED TO CONTAMINATION ON THE IUI CONNECTORS.

    Description of Event or Problem · 1

    AS PART OF A LOG REVIEW FOR AN EVENT WHICH WAS REPORTED BY THE CUSTOMER ON A DIFFERENT DEVICE, THIS DEVICE WAS IDENTIFIED AS BEING AN ADDITIONAL SUSPECT DEVICE FOR THE ISSUE OF A CHANNEL DISCONNECT DURING THE INFUSION OF MULTIPLE VASOACTIVE MEDICATIONS. THE CUSTOMER HAD REPORTED THAT UNSPECIFIED "IMMEDIATE INTERVENTION" WAS REQUIRED AS A RESULT OF THE DEVICE EVENT. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385355 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PCU: SN 13670668| ALARIS PUMP MODULE: SN (B)(4)| ALARIS PUMP MODULE TUBINGS: MODEL/LOT UNK| ALARIS PUMP MODULE: SN (B)(4)