BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19113398 · Received April 16, 2024

    Report

    Report Number
    3006575795-2024-00110
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 25, 2024
    Report Date
    April 3, 2025
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    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

    THIS SUPPLEMENT SERVES AS A CORRECTION AS PART OF OUR RETROSPECTIVE 2024 COMPLIANT REMEDIATION. THE PREVIOUSLY FILED MDR# 3006575795-2024-00110 SUBMITTED TO THE FDA IS A DUPLICATE OF MDR# 3006575795-2024-00115. REFER TO MDR#3006575795-2024-00115 FOR DETAILS. REFERENCE TO COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 FLOWRATE ISSUE AND 30PSI OCCLUSION SENSOR ISSUE WAS OBSERVED DURING PREVENTIVE MAINTENANCE ACTIVITIES PERFORMED AT ZYNO MEDICAL, LLC. CAUSE NOT ESTABLISHED SPECIFICALLY. YEARLY PREVENTIVE MAINTENANCE ACTIVITIES PERFORMED ON THIS DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 DURING SERVICING ACTIVITIES OF ZYNO MEDICAL, LLC WHICH INCLUDES PREVENTIVE MAINTENANCE THERE IS A FLOWRATE OFFSET% ISSUE WHERE FLOWRATE OFFSET% AT PRE-REWORK IS 6% AND AT POST-REWORK IT IS 1%. ALSO THERE IS 30PSI OCCLUSION SENSOR ISSUE OBSERVED WHERE 30PSI VALUE AT PRE-REWORK IS 274 AND AT POST REWORK IS 264. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582186 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20160517-SH 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown