BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19112214 · Received April 15, 2024

    Report

    Report Number
    3006575795-2024-00109
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 22, 2024
    Report Date
    March 19, 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

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

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT, THE REPORTED FLOW RATE FAILURE MODE HAS BEEN DETERMINED TO BE NON-REPORTABLE. EVENTS INVOLVING A SLOWER FLOW RATE ARE NOT REPORTABLE WHEN FLOW RATE ACCURACY IS BELOW -5% BUT ABOVE -15% SPECIFICATION. THE SEVERITY OF THIS FAILURE IS 1 - INCONVENIENCE OR TEMPORARY DISCOMFORT. OUR EVALUATION CONCLUDED THAT THE EVENT DID NOT POSE A RISK TO THE HEALTH OF PATIENTS, USERS, OR BYSTANDERS. FURTHERMORE, THE REPORT DID NOT ALLEGE A SERIOUS INJURY OR DEATH, NOR WOULD A RECURRENCE OF THE REPORTED ISSUE BE EXPECTED TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. REFER TO COMPLAINT #: (B)(4).

    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 -3% AND AT POST-REWORK IT IS 5%. NO PATIENT INVOLVED AS THIS IS OBSERVED DURING PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750865 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F F11029 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown