BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 17381615 · Received July 24, 2023

    Report

    Report Number
    3006575795-2023-00054
    Event Type
    Injury
    Date Received
    July 24, 2023
    Report Date
    July 24, 2023
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    UDI-DI
    00814371020013
    PMA / PMN Number
    K130690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED PUMP THAT DIDN'T STOP AFTER THE INFUSION WAS COMPLETE AND PUMPED AIR FOR APPROX 5 MIN. PATIENT HEARD THE PUMP MAKE A DIFFERENT SOUND BUT DIDN'T THINK ANYTHING IF IT. 5 MIN LATER PATIENT LOOKED UP AT THE BAG OF NS THAT WAS COMPLETELY EMPTY AND YELLED THAT IT WAS PUMPING AIR. 1000ML NS BAG WAS THE MED AND IT WAS SET AT 450ML/HR FOR A VOLUME OF 1200. THIS PT HAD SIGNIFICANT SEQUALAE AFTER THIS AIR EMBOLISM, PATIENT WAS VERY SYMPTOMATIC. MEDICATION BEING INFUSED WAS SALINE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271917 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800F 170103805 00814371020013

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention