BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO PUMP

    MDR report key: 13720595 · Received March 9, 2022

    Report

    Report Number
    MW5108003
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    March 7, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884481 ZYNO PUMP SET, ADMINISTRATION, INTRAVASCULAR FPA ZYNO MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other INFLECTRA