BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 11388752 · Received February 26, 2021

    Report

    Report Number
    3006575795-2021-00009
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE PROVIDER PROVIDED THE INVESTIGATION RESULT ON 03/16/2021. THE ACTUAL DEVICE WAS TESTED. THE PUMP FAILED THE FLOW RATE TESTING WITH A FLOW RATE DEVIATION OF 7.29%, WHICH IS OUTSIDE OF THE ±5% SPECIFICATION. THE REPORTED ISSUE WAS CONFIRMED. THE PUMP WAS CALIBRATED AND TESTED TO MEET FULL SPECIFICATION.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2021-00009).

    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 ON 02/05/2021 AND REPORTED THAT PUMP 903420 HAD AN INCONSISTENCY IN THE DRIP RATE. 100ML WOULD INFUSED IN 50 MINUTES AS APPOSED TO 1 HOUR. THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION BEING INFUSED WAS TYSABRI. THERE WAS A PATIENT INVOLVED. THE PATIENT WAS NOT HARMED OR INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280626 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800 20130123-SH 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1