BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 5342246 · Received January 4, 2016

    Report

    Report Number
    2016493-2016-00059
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Report Date
    December 16, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF AN UNEXPECTED BOLUS OR POSSIBLE HIGHER THAN EXPECTED FLOW RATES COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT PROVIDE A TIME OR DATE OF THE EVENT. IN ADDITION, NO DETAILS OF THE INTENDED INFUSION PARAMETERS WERE PROVIDED. BECAUSE THE ASSOCIATED PCU EVENT LOG WAS NOT AVAILABLE, THE EXACT PROGRAMMING AND DRUGS USED COULD NOT BE DETERMINED. TESTING AND INSPECTION OF THE PUMP MODULE FOUND NO MALFUNCTIONS, AND THE DEVICE TO BE INFUSING WITHIN SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EXPERIENCE WITH AN UNEXPECTED BOLUS, OR POSSIBLE COMPLETION OF INFUSION EARLIER THAN EXPECTED WAS NOT DETERMINED. THE PCU AND ADMINISTRATION SET WERE NOT RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DEVICE APPARENTLY DELIVERED AN UNEXPECTED BOLUS WHILE IN USE ON A PATIENT, INFUSION FLUID OR DRUG IS UNKNOWN. THERE IS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION, AND NO FURTHER INFORMATION HQA BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1