BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 8199636 · Received December 27, 2018

    Report

    Report Number
    2016493-2018-00991
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    September 24, 2018
    Report Date
    December 4, 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
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8120; 100ML BAXTER BAG NDC 0338-0705-48, LOT NUMBER P378638, EXP MAY 19, KCL; 250ML BAXTER BAG NDC 0338-0049-02, LOT NUMBER V18E08A, EXP NOV 19, 0.9% NACL; THERAPY DATE (B)(6) 2018. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS PARTIALLY CONFIRMED. THE PCU EVENT LOG SHOWED THAT AT 9:14 AM ON (B)(6) 2018 POTASSIUM WAS PROGRAMMED TO INFUSE 100ML OVER 2 HOURS. AT 9:16 AM THE USER CHANGED THE RATE FROM 50 ML/HR TO 25ML/HR. AT 10:17 AM THE USER CHANGED THE RATE BACK TO 50ML/HR. AT 10:24 THE DEVICE ALARMED FOR AIR IN LINE AND WAS SHUT DOWN A FEW MINUTES LATER. FUNCTIONAL TESTING RESULTED IN THE PUMP MODULE DELIVERING FLUID SLIGHTLY OUT OF SPECIFICATION ON THE HIGH SIDE. RATE CALIBRATION WAS PERFORMED AND THE VPMR WAS ADJUSTED. AFTER CALIBRATION, THE DEVICE WAS OBSERVED TO BE DELIVERING WITHIN SPECIFICATION. NO LEAKS OR OTHER ANOMALIES WERE OBSERVED WITH THE PRIMARY SET DURING INSPECTION AND TESTING. THE STARTING/ENDING VOLUME OF THE FLUID CONTAINER CANNOT BE DETERMINED THROUGH DEVICE LOGS. ALTHOUGH THE DEVICE WAS OBSERVED TO BE OUT OF SPECIFICATION ON THE HIGH SIDE WHEN TESTED AS RECEIVED, THE 4.25% ERROR WAS NOT ENOUGH TO HAVE CAUSED THE 100ML TO INFUSE IN 1 HOUR. THE ROOT CAUSE OF THE OVERINFUSION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NURSE STARTED 100ML OF POTASSIUM AT THE PRESCRIBED RATE OF 50ML/HR AT 0923. AFTER 5 MINUTES, THE PATIENT COMPLAINED OF SEVERE BURNING PAIN. THE NURSE RECEIVED AN ORDER TO DECREASE THE POTASSIUM RATE TO 25ML/HR AND ADDED 250ML OF SALINE AS A PRIMARY TO INFUSE AT 25 ML/HR WITH THE POTASSIUM. THE NURSE RETURNED AT 1018 AND THE POTASSIUM BAG WAS COMPLETELY EMPTY HOWEVER IT HAD BEEN EXPECTED TO INFUSE OVER 4 HOURS AT THE NEW REDUCED RATE. AS A RESULT, THE PATIENT REQUIRED A STAT VITAL SIGN CHECK AND EKG, AND WAS PLACED ON TELEMETRY MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040647 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 8015,8100,(2)2426-0007,PCA TUBE, TD (B)(6) 2018