BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 11528194 · Received March 19, 2021

    Report

    Report Number
    3006575795-2021-00017
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    March 11, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020532
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 05/13/2021, THE DISTRIBUTOR CONFIRMED THAT THE AFFECTED DEVICE WILL NOT BE RETURNED FROM THE CUSTOMERS. NO INVESTIGATION COULD BE PERFORMED. THE REPORTED ISSUE CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00017).

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL IS WAITING FOR THE ARRIVAL OF THE AFFECTED DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2021, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR AND STATED THAT AN ADMINISTRATION SET MODEL BX-70071-D LOT # 1810008 IS LEAKING RIGHT BELOW THE DRIP CHAMBER. THE USER FACILITY REPRESENTATIVE PROVIDED AN IMAGE WHICH SHOWS THE LEAKING. A PATIENT WAS INVOLVED BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. THE MEDICATION BEING INFUSED WAS UNKNOWN. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421579 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC BX-70071-D 1810008 00814371020532

    Patients

    Seq Age Sex Outcome Treatment
    1