BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 5682601 · Received May 26, 2016

    Report

    Report Number
    2016493-2016-00382
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    March 19, 2016
    Report Date
    May 3, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPAIRED THE DEVICE ON-SITE AND PUT IT BACK INTO SERVICE. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES: "BLOOD SUGAR (BS) WAS LOW 58; CHECKED PUMP TO SHUT IT OFF AND FOUND BAG TO BE EMPTY; HUNG AT 2200. OPENED CLAMP AND SMALL WHITE PIECE OF PUMP FELL OUT ON THE FLOOR. PATIENT RECEIVED INSULIN AT AN UNINTENDED RATE DUE TO CLAMP FAILURE." RELEVANT TESTS/LAB DATA STATES "DOOR LEVER INSPECTION AND REPAIR ON (B)(6) 2016: THE BROKEN WHITE PIECE WAS PART OF THE DOOR LEVER. THIS PIECE IS WHAT LOADS THE INFUSION SET INTO THE PUMP AND DISENGAGES THE INFUSION SET FREE FLOW FEATURE. WHEN DISENGAGED THE PUMP IS READY TO START AN INFUSION. OVER TIME, IF AN INFUSION SET IS INSERTED IMPROPERLY INTO THE PUMP, IT PUTS STRESS ONTO THIS WHITE PIECE WHICH EVENTUALLY BREAKS. THIS WOULD CAUSE A DOOR OPEN ERROR WHILE INFUSING. ANYWAY, I REPLACED THE DOOR LEVER ON THIS UNIT, TESTED IT AND PUT IT BACK IN SERVICE. " WHEN CONTACTED FOR ADDITIONAL INFORMATION THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD SUGARS HAD A WIDE RANGE BEFORE DURING AND AFTER THE EVENT, FROM THE 50'S TO HIGHS OF 300 TO 400. ON (B)(6) THE PATIENT'S BLOOD SUGAR WAS 180 AT MIDNIGHT, 129 AT 0200, 84 AT 0300, AND 58 AT 0408. AT 0430 THE CLINICIAN CHECKED THE PUMP AND NOTICED THE ENTIRE BAG OF 40ML WITH 40 UNITS OF INSULIN WAS EMPTY. (THE PATIENT HAD ALREADY RECEIVED 60ML OF INSULIN PRIOR TO THE EVENT). THE PATIENT WAS NOT HARMED AND WAS ASYMPTOMATIC HOWEVER THEY GAVE AN AMP OF D50 AS A PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338164 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PRI TUBING,8015, TD (B)(6) 2016