BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 17819868 · Received September 26, 2023

    Report

    Report Number
    3006575795-2023-00108
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 20, 2023
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FRN
    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

    ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. THIS PUMP PASSED ALL PREVIOUS TESTS. COMPLAINT DATA WAS REVIEWED, THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. ANALYSIS OF THE RETURNED DEVICE IS COMPLETE. THE RESULTS ARE BELOW: PUMP 500387 CAME IN WITH A COMPLAINT STATING THAT A PATIENT WAS HARMED AFTER THE PUMP CONTINUED TO INFUSE AFTER IT WAS SUPPOSED TO BE DONE AND IT NEVER ALARMED, CAUSING AIR TO ENTER THE PATIENT'S VEIN AND CAUSE THEM TO NEED MEDICAL ATTENTION. THE STATEMENT MENTIONS THAT THE PUMP WAS LAST INSPECTED 3/2023 BY BIOMEDTRONICS, WHO ARE NOT A ZYNO CERTIFIED VENDOR. THE PUMP ALSO HAS A STICKER ON IT FROM MCKESSON STATING THAT IT PASSED PM IN 8/2023, WHO IS A CERTIFIED VENDOR. THE PUMP WAS TESTED WITH THE FOLLOWING PROTOCOL: CONNECT TUBING INTO RESERVOIR. PRIME TUBING BY GRAVITY. TURN ON PUMP AND SET PROG TO 125ML/HR FOR 20 VTBI, SET AIR IN THE BIOMED OPTIONS TO 0.04 ML. TEST 1: RUN PUMP WITHOUT TUBING, PASS FIRST TEST IF IT ALARMS ¿AIR-IN-LINE¿. TEST 2: LOAD TUBING INTO THE PUMP AND HIT RUN, PASS IF PUMP DOES NOT ALARM ¿AIR-IN-LINE¿. TEST 3: RUN THE PUMP AND CREATE AN AIR BUBBLE ABOUT 1 INCH IN LENGTH, PASS IF THE PUMP ALARMS ¿AIR-IN-LINE¿. REPEAT STEPS 4-6 FOR A TOTAL OF 5 RUNS. THE PUMP WAS ABLE TO PASS ALL AIR-IN-LINE TESTS SUCCESSFULLY, ALARMING WHEN THE AIR BUBBLES PASSED THROUGH THE SENSOR EACH TIME AND IT ALSO ALARMED WHEN THE INFUSION WAS FINISHED. HOWEVER, THE PRESSURE SENSOR AND BATTERY NEEDED TO BE REPLACED, UPON POST THE PUMP HAD A BATTERY ERROR AND UPON INFUSING, THE PUMP WOULD ALARM "OCCLUSION" CONSTANTLY. BOTH COMPONENTS WERE REPLACED AND THE PUMP WAS TESTED TO SPEC. BATTERY AND PRESSURE SENSOR ARE ROOT CAUSES OF SECONDARY ISSUES. REPORTED ISSUE NOT FOUND. ADDITIONAL ISSUES FOUND AND CORRECTED. PUMP PERFORMING TO SPEC.

    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

    ON (B)(6) 2023, A DISTRIBUTOR OF ZYNO, RECEIVED AN EMAIL FROM AN EMPLOYEE OF ZANGMEISTER CENTER, AND THE FOLLOWING INFORMATION WAS RELAYED: ZANGMEISTER EXPERIENCED A ZYNO PUMP (B)(6) MALFUNCTION TODAY WITH THE AIR-IN-LINE-SENSOR. LAST INSPECTED (B)(6) BY BIOMEDTRONICS. THE PATIENT WAS RECEIVING GAMMAGUARD 30000MG. SHE WAS TITRATED BASED ON THE ACCORDINGLY RATE/VOL: 75/38, 113/56, 150/75, 188/94, 225/113, 263/131, 300/150. PATIENT BECAME ACUTELY RESTLESS, SHORT OF BREATH, O2 SATURATION OF 70%. PATIENT PLACED ON A 15L O2 VIA NON-REBREATHER WHERE OXYGEN SATURATIONS INCREASED TO 80¿-90¿S. NP CALLED CHAIRSIDE FOR ASSESSMENT. PATIENT O2 TITRATED DOWN TO 5L NASAL CANNULA WITH SATURATIONS BETWEEN 85%-90%. PATIENT CONTINUED TO FEEL RESTLESS DESPITE O2 INCREASE. DUE TO CONCERN FOR ACUTE PE, EMS WAS CONTACTED, AND PATIENT TRANSPORTED TO MCE. UPON ASSESSING THE PATIENT, THE INFUSION NURSE NOTICED THE GAMMAGUARD INFUSION HAD COMPLETED, BOTTLE WAS EMPTY, AIR WAS IN THE IV LINE AND HAD REACHED THE PATIENT. AT NO POINT DID THE PUMP STOP ONCE COMPLETED, ALARM, OR STOP BECAUSE OF AIR. X-RAY OF CHEST SHOWED PULMONARY HYPERTENSION, LOADED INTO PATIENT¿S CHART. INCIDENT REPORT COMPLETED AND LIST OF EVENTS ARE BELOW. GAMMAGUARD INFUSION COMPLETE HOWEVER IV LINE NOTED TO HAVE AIR IN LINE DESPITE PUMP NOT BEEPING AT THE COMPLETION OF INFUSION. 12:50 : PATIENT BECAME VERY RESTLESS AND STATED SHE COULDNT GET COMFORTABLE. T.G. THE RN CHECKED O2 SATS WHICH WERE 75%. THIS RN PLACED PATIENT ON NON-REBREATHER @ 15 L. 12:55: O2 SAT 80%. 12:58: O2 SAT 97%, HR 62, BP 106/54. 13:00: SWITCHED PATIENT BACK TO NASAL CANNULA 6L, O2 SAT 98%, HR 80. 13:02: M.L., APRN TO BESDSIDE, 3L NC, 94% O2 SAT, BP 104/57, HR 85. 13:10 4L NC 96% O2 SAT, BP 85/49, NORMAL SALINE WIDE OPEN AND 2ND PIV STARTED IN RLA. 13:22: 3L NC, 95% O2 SAT BP 99/62, SQUAD PHONED. 13:26: 2L NC 93% O2 SAT, BP 92/59, HR 80. 13:28 EMS ARRIVED ON FLOOR, 13:35 2L NC, 95% O2 SAT, PT STATES SHE FEELS MUCH BETTER. 13:40: PT LEFT FLOOR BY SQUAD TO MCE PER M. L., APRN AFTER PHONE CONVERSATION WITH PT'S DAUGHTER. BOTH PIVS LEFT IN. NO FURTHER DETAILS PROVIDED. INFUSION TOOK PLACE AT FACILITY. PATIENT INVOLVED. SEVERE ADVERSE EVENT INVOLVED. DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724763 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL LLC Z-800WF 20140108

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| H| R