BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6573487 · Received May 17, 2017

    Report

    Report Number
    2016493-2017-00344
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 2, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GTIN/UDI NUMBER FOR ITEM 8100ADXEN917, SN (B)(4) IS (B)(4). THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS NOT CONFIRMED. THE PCU EVENT LOG SHOWS THAT AT 9:25 AM ON (B)(6) 2017 THE PUMP MODULE WAS PROGRAMMED TO INFUSE PENICILLIN G AT A RATE OF 100ML/HR FOR 30 MINUTES. THE DEVICE ALARMED ONCE FOR PATIENT SIDE OCCLUSION AT 9:27 AM AND THE USER RESTARTED THE INFUSION. THEN AT 9:50 AM, THE USER CHANNELED THE DEVICE OFF. A FEW SECONDS LATER, THE USER POWERED ON THE SYSTEM AND PROGRAMMED THE DEVICE TO INFUSE PENICILLIN G AT A RATE OF 50ML/HR FOR 1 HOUR. APPROXIMATELY TWO MINUTES LATER AT 9:52 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 38.2ML. IT IS UNKNOWN WHY THE USER CHANNELED THE DEVICE OFF AT 9:50 AM AND THEN AGAIN AT 9:52 AM. THE STARTING VOLUME OF THE FLUID CONTAINER CANNOT BE DETERMINED THROUGH DEVICE LOGS. THE PUMP MODULE AND THE DISPOSABLE SET WERE NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE OVERINFUSION WAS NOT IDENTIFIED. DEVICES NOT RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A NURSE PROGRAMMED A PUMP TO INFUSE PENICILLIN G (2 MILLION U/50ML) OVER 30 MINUTES HOWEVER THE PUMP KEPT ALARMING FOR AN UNSPECIFIED REASON. THE NURSE CHANGED THE INFUSION DURATION TO 55 MINUTES HOWEVER THE MEDICATION INFUSED WITHIN 15 MINUTES. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353593 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)8100,8015,(3)PRI TUBING,TD (B)(6) 2017