BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800WF INFUSION PUMP SYSTEM

    MDR report key: 22098421 · Received May 28, 2025

    Report

    Report Number
    3006575795-2025-00179
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT SERVES AS A CORRECTION. UPON FURTHER EVALUATION, IT WAS DETERMINED THAT THE 30 PSI OCCLUSION TEST FAILURE DOES NOT MEET THE CRITERIA TO BE CLASSIFIED AS A COMPLAINT, AS THE PUMP HAD NOT BEEN RELEASED FOR DISTRIBUTION OR SHIPPED TO THE CUSTOMER. A NONCONFORMANCE RECORD (NC-2024-048) WAS INITIATED TO ADDRESS AND DOCUMENT THE ISSUE APPROPRIATELY. REFERENCE TO COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 39PSI WHICH IS OUTSIDE THE ACCEPTABLE RANGE OF 22 TO 38 PSI. A REVIEW OF THE DEVICE'S SERIAL NUMBER HISTORY REVEALED NO SIMILAR COMPLAINTS. THE FAILURE MODE WAS CONFIRMED, AND THE PROBABLE CAUSE WAS DETERMINED BE AN OUT-OF-CALIBRATION CONDITION. THE ISSUE WAS SUCCESSFULLY RESOLVED BY RECALIBRATING. CAPA-ZM2023-23 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE FOR THIS FAILURE MODE. REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    INTUVIE RECEIVED A REPORT INDICATING THAT AN INFUSION PUMP FAILED THE 30PSI OCCLUSION TEST, RECORDING A PRESSURE OF 18.120PSI WHICH IS OUTSIDE THE ACCEPTABLE RANGE OF 22 TO 38 PSI. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357988 ZYNO MEDICAL Z-800WF INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800WF 240520360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown