BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 3821237 · Received April 28, 2014

    Report

    Report Number
    3006575795-2014-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    January 14, 2014
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    PMA / PMN Number
    K100705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER DEVICE WAS EVALUATED AND THE DEVICE FAILED FLOW RATE ACCURACY TEST AT 125ML/HR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INFUSED AT A FLOW RATE OUTSIDE OF +/-5% SPECIFICATION. THE INFUSION OCCURRED AT A GREATER RATE THAN PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254453 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME PERISTALTIC INFUSION PUMP FRN ZYNO MEDICAL LLC. Z-800 20090507ZS5

    Patients

    Seq Age Sex Outcome Treatment
    1