BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PCA MODULE

    MDR report key: 6106528 · Received November 16, 2016

    Report

    Report Number
    2016493-2016-00871
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED INFUSION OF THE DRUG HYDROMORPHONE, 0.2MG/ML, HAVING INFUSED 39.9ML WHEN IT WAS EXPECTED TO INFUSE 55ML COULD NOT BE CONFIRMED OR DUPLICATED. THE PERTINENT INFORMATION WAS MISSING IN THE PCA EVENT LOG AND THE ASSOCIATED PCU AND ITS LOGS WERE NOT RETURNED FOR INVESTIGATION. TESTING AND INSPECTION OF RETURNED PCA MODULE FOUND NO MALFUNCTIONS AND THE DEVICE¿S ACCURACY TO BE WITHIN SPECIFICATION. VISUAL INSPECTION OBSERVED THAT THE DEVICE HAD SOME CRACKS IN THE FRONT PANEL ASSEMBLY AROUND THE SOCKET FOR THE PCA REQUEST CORD BUT THIS FINDING WAS DETERMINED TO BE AN INCIDENTAL OBSERVATION THAT DID NOT CONTRIBUTE TO THE CUSTOMER¿S REPORTED INCIDENT. THE ROOT CAUSE FOR THE ALLEGED PCA UNDER INFUSION IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFUSION OF HYDROMORPHONE .2 MG/ML WAS INTENDED TO INFUSE 55 ML AND INSTEAD INFUSED 39.9 ML. ALTHOUGH REQUESTED ADDITIONAL INFORMATION IS NOT AVAILABLE. THE CUSTOMER STATED A PROGRAMMING ERROR IS SUSPECTED; THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758686 ALARIS® PCA MODULE PUMP, INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 PCA TUBING,(B)(4), TD