BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 16710081 · Received April 10, 2023

    Report

    Report Number
    3006575795-2023-00009
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 10, 2023
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN OF THE DEVICE HAS BEEN REQUESTED. AS OF THE DATE OF THIS REPORT, DEVICE HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    THE PERFORMANCE TEST WAS PERFORMED ON Z-800F INFUSION PUMP, SERIAL NUMBER(B)(6) BY RUNNING A125ML INFUSION FOR 3 TEST PROTOCOLS, WHICH WERE RAN UNTIL FAILURE. FOR TEST PROTOCOL NUMBER 1 ALL 5 INFUSIONS ALERTED AIR IN LINE AS EXPECTED. FOR TEST PROTOCOL NUMBER 2 NO ERRORS WERE DETECTED AS REGULAR INFUSION PARAMETERS WERE RUN THROUGH. FOR TEST PROTOCOL NUMBER 3 ALL 5 INFUSIONS WHICH HAD A 1-INCH BUBBLE INTRODUCE A PROPER AIR-IN-LINE ERROR. THE CUSTOMER COMPLAINT THAT CONSTANT AIR-IN-LINE ALARMS OCCURRED WERE NOT VALIDATED. THE AIR IN LINE ISSUE WAS NOT CONFIRMED. THE PUMP WAS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    PRACTICE ADMINISTRATOR REPORTED "NOT DETECTING AIR IN THE LINE". THE NURSES CAUGHT THIS BEFORE ANY AIR MADE IT TO THE PATIENT. THE TREATMENT WAS CONTINUED WITH A DIFFERENT PUMP. INFUSION PARAMETERS: RATE OF 236 ML; VOLUME SET TO BE INFUSED WAS 200 ML; VOLUME IN INFUSION BAG 136 ML MEDICATION BEING INFUSED WAS SIMPONI ARIA. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755733 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800F 170830400 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown