BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10978832 · Received December 9, 2020

    Report

    Report Number
    3006575795-2020-00045
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    October 23, 2019
    Report Date
    November 23, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020174
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED SET WAS NEVER RETURNED FOR EVALUATION. THE DISTRIBUTOR CONFIRMED THAT THE CUSTOMER WAS NOT CLAMPING BELOW THE FILTER. THE CUSTOMER STATED THAT, "YOU WERE EXACTLY RIGHT. I TESTED IT OUT WITH CLAMPING IT OFF BELOW THE FILTER, AND IT DID NOT BACK UP. I HAVE RETRAINED MY GIRLS, AND WE ARE GOOD."

    Description of Event or Problem · 1

    ON 11/23/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 10/24/2019, AND STATED THAT ADMINISTRATION SET MODEL#: B2-70071-DF LOT#: 1810012 FILTER DRAINS BACK, AND THEN WHEN THEY TURN THE PUMP ON THERE IS ABOUT 6 INCHES OF AIR. 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
    1441600 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC B2-70071-DF120 1810012 00814371020174

    Patients

    Seq Age Sex Outcome Treatment
    1