BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO PUMP

    MDR report key: 13141748 · Received December 30, 2021

    Report

    Report Number
    MW5106399
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    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 TRANSPIRED IN AN INFUSION SUITE. PT HAD RECEIVED THIS MEDICATION 3 TIMES PRIOR TO THIS VISIT. PT WAS GIVEN INFLECTRA 400MG VIA PIV ON (B)(6) 2021 AT A SLOWER RATE OF 75ML/HR D/T PT HAVING SOME NAUSEA THE LAST INFUSION. PT HAD TAKEN ORAL BENADRYL 25MG PO AND 500MG PO TYLENOL PRIOR TO INFUSION 30MIN. PT WAS ISSUING IN CHAIR AND WATCHED CAREFULLY BY INFUSION RN. INFUSION WAS STARTED AT 1515 AND BY 1523 PT STARTED TO HAVE TROUBLE BREATHING AND C/O CHEST DISCOMFORT. INFUSION WAS STOPPED AND PT HAD BY THIS TIME TURNED "PURPLE". PT BEGAN TO VOMIT AS RN CALLED 911 WHILE ADMINISTERING 1MG EPINEPHRINE IV AND OPENING NS FLUIDS WIDE TO THE PT'S PIV. PT WAS ALSO GIVEN 25MG IV DIPHENHYDRAMINE. EMS ARRIVED BY 1528 AND PT HAD RECOVERED BY THAT POINT AND STOPPED VOMITING AND WAS ABLE TO BREATH AND DENIED ANY CHEST DISCOMFORT. PT WAS TAKEN TO LOCAL HOSPITAL ED AND EVALUATED FOR 5 HOURS POST EPISODE TO MAKE SURE PT DID NOT HAVE ANY FURTHER DISTRESS OR ANAPHYLAXIS REBOUND. PT'S MOTHER KEPT IN TOUCH WITH RN AND PT WAS DOING WELL BUT SLEEPY FROM THE BENADRYL. MD WAS NOTIFIED AS WELL AS ADMIN TEAM AND PHARMACY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021466 ZYNO PUMP PUMP, INFUSION FRN ZYNO MEDICAL LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other PFIZER INFLECTRA 400 MG, UNIQUE ID: (B)(4), LOT FD1719, EXP: 08/31/2025, DOSE: 250 ML, 02/22/2021-11/19/2021