BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 8025477 · Received October 31, 2018

    Report

    Report Number
    2016493-2018-00799
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 18, 2018
    Report Date
    October 25, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 500ML BAXTER BAG NDC 0060364 LOT NUMBER W8E31B1 EXP AUG 19 5% DEXTROSE. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS NOT CONFIRMED. PHYSICAL INSPECTION OF THE DEVICE SHOWED NO ANOMALIES. THE PCU EVENT LOG SHOWS THAT THE PUMP MODULE WAS PROGRAMMED TO INFUSE D10W AT A RATE OF 6.3ML/HR WITH A VTBI OF 30ML AT 11:52 PM ON (B)(6) 2018. ADDITIONAL VTBI WAS ADDED SEVERAL TIMES AND THE INFUSION RESTARTED WHEN THE PRIMARY INFUSION COMPLETED AND THE DEVICE TRANSITIONED TO KVO. AT 10:04 AM ON (B)(6) 2018, THE DEVICE ALARMED FOR PATIENT SIDE OCCLUSION. AT 10:07 AM, THE USER CHANNELED THE DEVICE OFF AND THE SYSTEM WAS SHUT DOWN AND POWERED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 64.112ML. FUNCTIONAL TESTING OF THE PUMP MODULE SHOWED NO ANOMALIES. NO LEAKS OR OTHER ISSUES WERE NOTED WITH THE PRIMARY SET. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT 500ML OF D10W WAS PROGRAMMED TO INFUSE AT 6.3ML/HR ON (B)(6) 2018 AT 2353. THE FOLLOWING MORNING, ON (B)(6) 2018 AT 0830, THE PATIENT'S BLOOD GLUCOSE WAS 63MMOL/L. AT APPROXIMATELY 1000 THE IV FLUID WAS CHANGED TO 0.45 NS DUE TO THE HYPERGLYCEMIA. BY 1415 THAT DAY THE PATIENT'S BLOOD GLUCOSE HAD DECREASED TO 5.5MMOL/L. THE PATIENT'S URINE OUTPUT ON 10/18/18 WAS AS FOLLOWS: AT 0300 IT WAS 28ML, AT 0600 IT WAS 131ML, AND AT 0800 IT WAS 88ML. NO OTHER INTERVENTIONS WERE REQUIRED AND THE PATIENT'S URINE OUTPUT WAS INCREASED ALONG WITH BODY WEIGHT. THE GLUCOSE WAS ELEVATED CRITICALLY BUT NORMALIZED WITHIN 14 HOURS OF THE EVENT AS NOTED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 500ML OF D10W WAS PROGRAMMED TO INFUSE AT 6.3ML/HR ON (B)(6) 2018 AT 2353. THE FOLLOWING MORNING, ON (B)(6) 2018 AT 0830, THE PATIENT'S BLOOD GLUCOSE WAS 63MMOL/L. AT APPROXIMATELY 1000 THE IV FLUID WAS CHANGED TO 0.45 NS DUE TO THE HYPERGLYCEMIA. BY 1415 THAT DAY THE PATIENT'S BLOOD GLUCOSE HAD DECREASED TO 5.5MMOL/L. THE PATIENT'S URINE OUTPUT ON (B)(6) 2018 WAS AS FOLLOWS: AT 0300 IT WAS 28ML, AT 0600 IT WAS 131ML, AND AT 0800 IT WAS 88ML. NO OTHER INTERVENTIONS WERE REQUIRED AND THE PATIENT'S URINE OUTPUT WAS INCREASED ALONG WITH BODY WEIGHT. THE GLUCOSE WAS ELEVATED CRITICALLY BUT NORMALIZED WITHIN 14 HOURS OF THE EVENT AS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866606 ALARIS® PUMP MODULE INFUSION PUMP FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention 2420-0007,8015, TD: (B)(6) 2018| 8110, SYRINGE SET| 2420-0007,8015, TD: (B)(6) 2018