BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 8936114 · Received August 27, 2019

    Report

    Report Number
    3006575795-2019-00025
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    August 14, 2019
    Report Date
    November 22, 2019
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PUMP RETURNED FROM THE CUSTOMER WAS TESTED BY THE SERVICE PROVIDER. ZYNO MEDICAL RECEIVED THE EVALUATION REPORT FROM THE SERVICE PROVIDER ON 11/22/2019. THE REPORTED "FLOW RATE" ISSUE COULDN'T BE REPEATED. THE PUMP PASSED THE TEST, AND THE FLOW RATE WAS WITHIN SPECIFICATION. THE COMPLAINT COULDN'T BE CONFIRMED.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2019-00025).

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL IS WAITING FOR THE ARRIVAL OF THE AFFECTED PUMP TO PERFORM THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 8/22/2019, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A FLOW RATE ISSUE OF THE PUMP. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 8/22/2019, STATING THAT "PUMP (B)(4) WAS INFUSING TOO QUICKLY." SHE STATED "SOMETIMES IT SAYS THERE'S MORE IN THE BAG THAN THERE ACTUALLY IS." SHE ALSO STATED THAT "SOMETIMES THE PUMP WOULD COMPLETE AN INFUSION AND THERE WOULD STILL BE A SIGNIFICANT AMOUNT OF MEDICATION LEFT IN THE BAG." MEDICATION USED WAS GAMMAKED. A PATIENT WAS INVOLVED, BUT THERE WAS NO HARM. THE DEVICE OPERATOR WAS A REGISTERED NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729212 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800 20130123-SH 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1