BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3952028 · Received July 16, 2014

    Report

    Report Number
    2016493-2014-00368
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 07/16/2014. INTERNAL FILE NO: (B)(4). REFERENCE ASSOCIATED MFR REPORT: 2016493-2014-00293. A REVIEW OF THE PCU EVENT LOG INDICATES THAT DURING THE THERMAL EVENT AT THE IUI CONNECTION, THE SYSTEM EXPERIENCED CHANNEL DISCONNECTED ALARMS. AFTER THE CHANNEL DISCONNECTED ALARMS, THE SYSTEM RECORDED THE OCCURRENCE OF ERROR CODE 120.4410.0 (LOW BACKUP VOLTAGE FAILURE). VISUAL INSPECTION CONFIRMED THE LEFT IUI CONNECTOR ON PUMP MODULE SN: (B)(4) HAD THERMAL DAMAGE AT THE SAME PIN NUMBERING AS THE FIRST SUSPECT DEVICE (SN: (B)(4)) AND APPEARED TO BE COLLATERAL DAMAGE. THIS DEVICE ALSO HAD CONTAMINATION/CORROSION ON THE PINS OF THE IUI CONNECTOR. THE IUI CONNECTOR HAD A DATE CODE OF JUNE 2007. THE PROXIMATE CAUSE FOR THE REPORTED ISSUE OF BURNED IUI CONNECTORS IS BEING ATTRIBUTED TO THE THERMALLY DAMAGED IUI CONNECTOR ON THE PUMP MODULE. THE ROOT CAUSE FOR THE THERMAL EVENT IS NOT DEFINITIVELY KNOWN BUT THE PRESENT OF DRIED FLUID RESIDUE OBSERVED ON THE DEVICE SUGGESTS FLUID INGRESSION INTO THE CONNECTOR AT SOME POINT WAS THE MOST LIKELY CAUSE.

    Description of Event or Problem · 1

    THIS MODULE WAS IDENTIFIED AS AN ADD'L SUSPECT DEVICE FOR A PREVIOUSLY REPORTED EVENT OF IUI CONNECTORS THAT BURNED DURING PT USE. THE INVESTIGATION FOUND THAT THIS MODULE HAD BEEN INFUSING AN UNSPECIFIED BASIC INFUSION AT 50 ML/HR AT THE TIME OF THE EVENT. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415891 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SNS: (B)(4)| ALARIS PCU SN (B)(4), ALARIS PUMP MODULE,| ALARIS ADMIN SETS, MODELS/LOTS UNK