BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-800F

    MDR report key: 24012904 · Received January 8, 2026

    Report

    Report Number
    3006575795-2026-00845
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE DEVICE EVALUATION. TESTING OF THE ULTRASONIC PROCESSING BOARDS (VISUAL INSPECTION, IMAGING, AND TARGETED THERMAL STRESS OF DFMEA-IDENTIFIED COMPONENTS) DID NOT IDENTIFY DEBRIS, SIGNAL INSTABILITY, OR FUNCTIONAL ANOMALIES. THE ULTRASONIC AIR-IN-LINE DETECTION CIRCUITRY PERFORMED AS INTENDED UNDER BOTH EMPTY-TUBING AND LIQUID-PRESENT CONDITIONS. REFERENCE TO COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 0

    THE ALLEGATION OF THE DEVICE NOT ALARMING WHEN AIR WAS PRESENT IN THE LINE WAS EVALUATED DURING COMPLAINT INVESTIGATION (B)(4). INITIAL TESTING OF THE DEVICE INCLUDED AIR-IN-LINE ALARM TESTING, DURING WHICH THE DEVICE PASSED THE AIR-IN-LINE TEST AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. DURING TESTING, IT WAS NOTED THAT A DIFFERENT POWER CORD WAS SHIPPED WITH THE DEVICE AND THE BATTERY DID NOT FULLY CHARGE. THESE CONDITIONS WERE NOT ASSOCIATED WITH THE REPORTED ALLEGATION. ALL OTHER APPLICABLE FUNCTIONAL TESTING, INCLUDING PRESSURE AND OCCLUSION TESTING, MET SPECIFICATION. THE COMPLAINT WAS NOT CONFIRMED. THE REPORTED ISSUE COULD NOT BE REPRODUCED THEREFORE THE PROBABLE CAUSE REMAINS UNDERMINED. REFERENCE TO COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE¿S SERIAL NUMBER HISTORY REVEALED NO PRIOR SIMILAR COMPLAINTS. AT THE TIME OF THIS REPORT, THE DEVICE IS IN RETURN TRANSIT TO INTUVIE FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. IT WAS REPORTED THAT THE PUMP WAS CLEANED PRIOR TO THE INFUSION. UPON VISUAL INSPECTION, THE CLINICIAN DID NOT OBSERVE ANY LIQUID OR EXCESSIVE MOISTURE ON OR AROUND THE AIR-IN-LINE SENSOR. THE INFUSION WAS PROGRAMMED USING 10-SET MODE. A REF B2-70071-D ADMINISTRATION SET WAS USED DURING THE INFUSION; THE LOT NUMBER IS UNKNOWN. THE INFUSION SET WAS DISCARDED FOLLOWING THE EVENT AND IS NOT AVAILABLE FOR RETURN OR EVALUATION. INTUVIE HAS PREVIOUSLY INITIATED CAPA- ZM2023-08 TO INVESTIGATE THE ROOT CAUSE FOR AIR IN LINE FAILURES. REFERENCE TO COMPLAINT#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTUVIE ON DECEMBER 12, 2025, THAT ON (B)(6) 2025, A PATIENT ARRIVED AT AN INFUSION CENTER ALERT, ORIENTED, AND AMBULATORY FOR AN INTRAVENOUS IMMUNOGLOBULIN (IVIG) INFUSION. THE PATIENT STATED THAT HE FELT WELL AND THAT HIS SYMPTOMS WERE WELL CONTROLLED AT THAT TIME. THE INFUSION WAS INITIATED AT APPROXIMATELY 9:30 A.M. USING A ZYNO Z-800F INFUSION PUMP (SERIAL NUMBER (B)(6)). THE PROGRAMMED INFUSION RATE WAS 274 ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 256 ML. THE PATIENT REPORTED TAKING PRESCRIBED PRE-MEDICATIONS PRIOR TO ARRIVAL, INCLUDING DIPHENHYDRAMINE (BENADRYL) 25 MG BY MOUTH. THE PATIENT INITIALLY TOLERATED THE INFUSION, AND VITAL SIGNS REMAINED STABLE. AT APPROXIMATELY 1:50 P.M., THE PATIENT EXITED THE INFUSION ROOM AND REPORTED SHORTNESS OF BREATH (SOB), STATING HE FELT UNABLE TO TAKE A FULL BREATH AND WAS EXPERIENCING CHEST PRESSURE. THE NURSE OBSERVED THAT THE SECOND IVIG BOTTLE WAS EMPTY WHILE THE INFUSION PUMP CONTINUED RUNNING. UPON INSPECTION, NO FLUID WAS PRESENT IN THE IV TUBING. IT WAS REPORTED THAT THE PUMP DID NOT ALARM FOR ¿AIR IN LINE.¿ THE INFUSION PUMP WAS IMMEDIATELY STOPPED AND DISCONNECTED. A SECOND NURSE WAS ASKED TO ASSIST. AT THAT TIME, THE PATIENT¿S VITAL SIGNS WERE RECORDED AS FOLLOWS: BLOOD PRESSURE 119/75 MMHG, HEART RATE 90 BPM, OXYGEN SATURATION 96%, AND RESPIRATORY RATE 18 BREATHS PER MINUTE. THE PATIENT ALSO REPORTED NAUSEA AND WAS OBSERVED TO APPEAR PALE/GREY IN COMPLEXION. SUPPLEMENTAL OXYGEN WAS INITIATED AT 4 L/MIN VIA NASAL CANNULA FOR COMFORT. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR EVALUATION AND TRANSPORT TO THE EMERGENCY DEPARTMENT (ED). NURSING SUPERVISORS WERE NOTIFIED. THE PATIENT¿S VITAL SIGNS WERE REASSESSED TWO ADDITIONAL TIMES AND REMAINED STABLE. THE PATIENT CONTINUED TO REPORT SYMPTOMS OF SHORTNESS OF BREATH, CHEST PRESSURE, AND NAUSEA. EMS ARRIVED AT APPROXIMATELY 2:15 P.M. AND TRANSPORTED THE PATIENT TO THE LOCAL EMERGENCY DEPARTMENT. AT APPROXIMATELY 2:33 P.M., THE NURSE CONTACTED THE PROVIDER¿S OFFICE AND SPOKE WITH ANOTHER NURSE TO REPORT THE EVENT. BASED ON THE PUMP SETTINGS AND TIMING, THE NURSE ESTIMATED THAT THE PUMP CONTINUED RUNNING FOR APPROXIMATELY 24 MINUTES AFTER THE IVIG BOTTLES WERE EMPTY AT A RATE OF 274 ML/HR, RESULTING IN AN ESTIMATED AIR VOLUME OF APPROXIMATELY 110 ML ENTERING THE LINE. AN INITIAL ESTIMATE OF APPROXIMATELY 140 ML WAS REPORTED TO EMS. THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT ON (B)(6) 2025, FOR OBSERVATION AND EVALUATION. HE WAS SUBSEQUENTLY DISCHARGED (EXACT DATE UNKNOWN) AND REFERRED FOR FOLLOW-UP WITH CARDIOLOGY AND PULMONOLOGY. IT IS UNKNOWN WHAT INTERVENTIONS WERE PERFORMED DURING THE HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75571 Z-800F PUMP, INFUSION FRN ZYNO MEDICAL, LLC Z-800F IV INFUSION PUMP 200406416

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| L| R