BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 20058781 · Received August 24, 2024

    Report

    Report Number
    3006575795-2024-00656
    Event Type
    Malfunction
    Date Received
    August 24, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 24, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE PREVIOUS COMPLAINTS ON THE DEVICE NOT RELATED TO THE REPORTED ISSUE. HISTORICAL RECORDS WERE REVIEWED. IT WAS DISCOVERED THAT THERE WERE DISCREPANCIES IN THE TEST RECORDS. NCR #2024-018 HAD BEEN INITIATED TO ADDRESS THE DISCREPANCIES. THIS PUMP UNDERWENT ROUTINE MAINTENANCE TESTING WHERE IT WAS DETECTED THE PUMP HAD SYSTEM ERROR. CONSEQUENTLY, IT NECESSITATED AN ADJUSTMENT TO THE PUMP'S FLOWRATE %. IT WAS CONFIRMED THE RECALIBRATION ADDRESSED THE ISSUE SUCCESSFULLY. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. REFERENCE TO COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    ON 08/01/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE PUMP FAILED DURING BURN IN WITH A SYSTEM ERROR. NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481399 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20160628-SH 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown