BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10978852 · Received December 9, 2020

    Report

    Report Number
    3006575795-2020-00044
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    December 3, 2019
    Report Date
    November 23, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED FOR EVALUATION. NO ROOT CAUSE WAS ESTABLISHED.

    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 12/03/2019 AND STATED THAT A PUMP 901717 WOULD NOT OCCLUDE AND THE VOLUME INFUSION WAS TOO HIGH. THERE WAS NO PATIENT INVOLVEMENT. NO INFORMATION WAS PROVIDED FOR THE DEVICE OPERATOR OR THE MEDICATION BEING INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442431 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800 20110815-SH 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1