BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 14161831 · Received April 20, 2022

    Report

    Report Number
    3006575795-2022-00013
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 7, 2022
    Report Date
    June 16, 2022
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZYNO MEDICAL IS TRYING TO GET CONTACT WITH THE END USER TO HAVE THE DEVICE SEND BACK FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    ZYNO MEDICAL TRIED TO CONTACT THE END USER FOR THREE TIMES BUT GOT NO RESPONSES. THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. NO ROOT CAUSE COULD BE ESTABLISHED.

    Description of Event or Problem · 0

    ON 03/31/2022 ZYNO MEDICAL RECEIVED A LETTER (REPORT #MW5108003) FROM THE FDA. THE EVENT DESCRIPTION WAS "EVENT HAPPENED AT INFUSION SUITE. PT HAS RECEIVED THE MEDICATION 3 TIMES PRIOR TO TODAYS INFUSION. PT WAS GIVEN INFLECTRA 600 MG VIA PIV. INFUSION STARTED AT 1034. PT STARTED COMPLAINING SOMETHING WAS WRONG AT 1041 AM. INFUSION STOPPED IMMEDIATELY AND NS STARTED VIA GRAVITY WIDE OPEN. BENADRYL GIVEN AT 1043; 911 CONTACTED AT 1044 AND ARRIVED BY 1050. RN GAVE FULL REPORT TO EMTS. DURING EMT ASSESSMENT THEY ADMINISTER ZOFRAN AND ATTACHED LEADS FOR HEART MONITORING. EMTS TOOK PATIENT TO (B)(6) ER. RN MANAGER CONTACTED HOSPITAL FOR UPDATE. AT 1230. PATIENT WAS STABLE. THEY HAVE HER ON A SOLUMEDROL DRIP. GIVEN HER FAMOTIDINE IV. AND ANOTHER DOSE OF BENADRYL. SHE WAS GOING TO BE MONITORED FOR A COUPLE MORE HOURS BEFORE DETERMINING IF SHE CAN GO HOME. FDA SAFETY REPORT ID #:(B)(4)." DEVICE OPERATOR WAS A HEALTH PROFESSIONAL. THE PATIENT INVOLVED WAS REPORTED TO HAVE SERIOUS INJURY WITH HEALTH EFFECT-CLINICAL CODE IDENTIFIED AS 1907: HYPERSENSITIVITY/ALLERGIC REACTION. THE MEDICAL DEVICE PROBLEM CODE WAS REPORTED TO BE 2993: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2022-00013).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274375 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R