BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 21197808 · Received January 21, 2025

    Report

    Report Number
    3006575795-2025-00016
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    May 17, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT SERVES AS A CORRECTION. THIS MDR# 3006575795-2025-00016 WAS SUBMITTED TO THE FDA INADVERTENTLY. THIS IS A DUPLICATE OF MDR# 3006575795-2024-00405-1 SUBMITTED ON 27NOV2024. REFERENCE TO COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED TO THE FOOD DRUG AND ADMINISTRATION LATE AS PART OF OUR AGING COMPLIANT REMEDIATION. A MEDWATCH 3500A VOLUNTARY REPORT (MW5155207) WAS SUBMITTED TO INTUVIE (FORMERLY ZYNO MEDICAL) REGARDING A SERIOUS INJURY. THE REPORT WAS THE ONLY ONE RECEIVED FROM THE FACILITY. HOWEVER, DUE TO THE ABSENCE OF THE DEVICE, SERIAL/LOT INFORMATION, AND CUSTOMER CONTACT DETAILS, A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. BASED ON INTUVIE'S MEDICAL ASSESSMENT, THE EVENT IS LIKELY ATTRIBUTABLE TO A DRUG REACTION RATHER THAN A MEDICAL DEVICE ISSUE. REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    A MEDWATCH 3500A VOLUNTARY REPORT (MW5155207) WAS SUBMITTED TO INTUVIE (FORMERLY ZYNO MEDICAL) INDICATING A SERIOUS INJURY. SEE THE REPORTED INFORMATION BELOW: 1239- PATIENT HAD RIGORS/ SHAKING ALL OVER HER BODY. 1239- BP (BLOOD PRESSURE)-147/94 HR (HEARTRATE)-78. R-16 TEMP-96.7 O2-97% 1240- (B)(6) FNP (FAMILY NURSE PRACTIONER) NOTIFIED AND FNP INSTRUCTED TO GIVE BENADRYL 25MG, PEPCID 20MG, QUZYTTIR 10MG IV, AND TYLENOL 1000MG 1240-TYLENOL 1000MG GIVEN PO 1246- BENADRYL 25MG IV, PEPCID 20MG, QUZYTTIR V 10MG GIVEN 1249- BP-160/100 HR-92 O2-98 % R-18 1253- BP-131/100. HR-88 O2-98 R-16 1303- BP0163/91 HR-80 O2-98 R-16 1315- PATIENT RIGORS/SHAKING RESOLVED AND PATIENT STATED THEY DO NOT WANT TO RECONTINUE DUE TO BEING IN EMOTIONAL DISTRESS. 1316- MEDICATION WASTED 76MLS AND PATIENT RECEIVED 124MLS 1325- PATIENT BP-156/80 HR-79 O2-98 TEMP-97 PATIENT FAMILY MEMBER PICKED UP PATIENT. (B)(6). INSTRUCTED PATIENT TO GO TO THE ER (EMERGENCY ROOM) IF ANY SIGNS AND SYMPTOMS OF A REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723333 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z-800

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention