BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 20114834 · Received August 31, 2024

    Report

    Report Number
    3006575795-2024-00707
    Event Type
    Malfunction
    Date Received
    August 31, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 31, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020037
    PMA / PMN Number
    K130690
    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 NO PREVIOUS COMPLAINTS ON THE DEVICE. TESTING RESULTS 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 BY "INTUVIE" PROVIDER WHERE IT WAS DETECTED THAT THE 30 PSI VALUE (P.I) FAILED UNDER THE REQUIRED PARAMETERS AND NEEDED TO BE CALIBRATED. THE PUMP CALIBRATION CONFIRMED TO HAVE SUCCESSFULLY ADDRESSED THE ISSUE. 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 08/09/2024, ZNYO MEDICAL RECEIVED A REPORT THAT DURING THE PREVENTIVE MAINTENANCE (PM), THE DEVICE HAD FAILED THE 30 PSI. RECALIBRATED 30 PSI FROM 310 TO 290. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804385 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800WF 201016280 00814371020037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose