BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 16787579 · Received April 21, 2023

    Report

    Report Number
    3006575795-2023-00026
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH DATA REVIEWED FORM: (B)(6) 2021 TO (B)(6) 2023. A BATCH RECORD REVIEW WAS COMPLETED, AND NO ISSUES WERE FOUND. PERFORMANCE TEST WAS PERFORMED ON Z-800F INFUSION PUMP, SERIAL NUMBER (B)(4), BY RUNNING A 20ML INFUSION. WHEN INFUSION WAS COMPLETED, PUMP ALARMED "INFUSION COMPLETED" AND ALARM WAS AUDIBLE. A SECOND 20ML INFUSION WAS PERFORMED AND IT WAS CONFIRMED THAT THE DOOR OPEN ALARM, AIR IN LINE ALARM, AND OCCLUSION ALARM WERE TRIGGERED AND AUDIBLE. THE SPEAKER ISSUE WAS NOT CONFIRMED. THE PUMP WAS OPERATING WITHIN SPECIFICATIONS. THE PUMP EVALUATION WAS COMPLETED ON (B)(6) 2023.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PUMP "NOT ALARM AFTER THE INFUSION WAS COMPLETE". IT WAS ALSO REPORTED THAT AIR ENTERED THE PATIENT'S LINE. TUBING WAS COMPLETELY EMPTY OF FLUID. THE DEVICE DID NOT ALARM FOR AIR IN LINE. PATIENT DID NOT REQUIRE ADDITIONAL TREATMENT. PUMP DID NOT HAVE ANY OBVIOUS PHYSICAL DAMAGE. THE PATIENT WAS DISCONNECTED. MEDICATION BEING INFUSED WAS UNKNOWN. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684223 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800F 20111005-SH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.