BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 17374613 · Received July 21, 2023

    Report

    Report Number
    3006575795-2023-00053
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Report Date
    July 21, 2023
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FLOWRATE TEST WAS PERFORMED ON Z-800WF INFUSION PUMP, SERIAL NUMBER (B)(6). THE INITIAL TEST ABOVE WAS PERFORMED AND IS WORKING AS IT SHOULD NO ISSUES FOUND. THE PUMP PASSED THE FLOWRATE TEST WITH A FLOWRATE OF 124.86 AND DEVIATION 2.13. THE PUMP IS OPERATING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED "PUMP IS DELIVERING AT A SLOWER RATE THAN PROGRAMMED (UNDER DELIVERY)." MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255094 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800WF 20161021-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown