BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 19706010 · Received July 9, 2024

    Report

    Report Number
    3006575795-2024-00405
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    May 17, 2024
    Report Date
    November 27, 2024
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    K130690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED TO THE FOOD DRUG AND ADMINISTRATION LATE AS PART OF OUR AGING COMPLIANT REMEDIATION. INTUVIE RECEIVED ONLY ONE VOLUNTARY MEDWATCH REPORT (MW5155207) FROM THE FACILITY. THE REPORT DID NOT INDICATE A DEVICE MALFUNCTION. THE DEVICE WAS NOT RETURNED, AND SERIAL/LOT INFORMATION AS WELL AS CUSTOMER CONTACT DETAILS ARE UNAVAILABLE. AS A RESULT, A REVIEW OF THE DEVICE HISTORY COULD NOT BE PERFORMED. BASED ON THE ASSESSMENT OF THE EVENT DESCRIPTION PROVIDED IN THE REPORT, THE EVENT APPEARS TO BE RELATED TO A DRUG REACTION RATHER THAN A MEDICAL DEVICE ISSUE. REFERENCE TO COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED OVER THE PUMP IN THE FIRST OR THE SECOND REPORT SUBMITTED TO THE FDA BY THE CUSTOMER. NOR INFORMATION ABOUT THE MEDICATION THE PATIENT WAS BEING ADMINISTERED AT THE TIME OF THE APPARENT ALLERGIC REACTION. INTUVIE, DECIDED TO SUBMIT THIS REPORT AS AN INITIAL REPORT FOLLOWING AN MDR REPORT THAT WAS ALREADY SUBMITTED TO THE FDA BY THE CUSTOMER DUE TO THEIR APPARENT ALLERGIC REACTION. PER THE Z-800F INFUSION PUMP, INFORMATION FOR USE (IFU) THE PUMP IS INTENDED TO PROVIDE ACCURATE DELIVERY OF PARENTERAL FLUIDS, BLOOD AND BLOOD PRODUCTS TO A HUMAN PATIENT WHEN ADMINISTERED BY A QUALIFIED HEALTH CARE PROFESSIONAL. THE PUMP ITSELF WOULD NOT CAUSE AN ALLERGIC REACTION TO THE PATIENT WITHOUT MEDICATION BEING ADMINISTERED. THE COMPLAINT WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE AND A FOLLOW UP MDR WILL BE SUBMITTED WITH THE ADDITIONAL NEW INFORMATION.

    Description of Event or Problem · 0

    INTUVIE RECEIVED ONLY ONE VOLUNTARY MEDWATCH REPORT (MW5155207) FROM THE FACILITY. THE REPORT DID NOT INDICATE A DEVICE MALFUNCTION: 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. FNP (B)(6). INSTRUCTED PATIENT TO GO TO THE ER (EMERGENCY ROOM) IF ANY SIGNS AND SYMPTOMS OF A REACTION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE FDA, STATING AN MDR HAD BEEN SUBMITTED BY A CUSTOMER. CUSTOMER STATED THAT THE DEVICE WAS REPORTED THAT THE PUMP SAID IT WAS INFUSING AT 366ML/HR, BUT IT WAS NOT DRIPPING IN THE CHAMBER. IT WAS CONFIRMED A KINK WAS FOUND IN THE TUBING ABOVE THE PUMP DOOR. THE IV WAS FLUSHED AND IT STARTED TO WQRK. PER A SECOND MDR REPORT SUBMITTED TO THE FDA, ON BEHALF OF THE PATIENT. THE PATIENT EXPERIENCED HAD RIGORS/ SHAKING ALL OVER HER BODY. THE PATIENT VITALS WERE TAKEN AT 1239PM- BP (BLOOD PRESSURE )-147/94 HR (HEARTRATE)-78, R-16 TEMP-96.7 O2-97%. THE FAMILY NURSE PRACTIONER (FNP) WAS 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. AT 1249PM PATIENT'S VITALS WERE- 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. AT 1315PM THE PATIENT RIGORS/SHAKING WERE RESOLVED AND PATIENT STATED THEY DO NOT WANT TO RECONTINUE DUE TO BEING IN EMOTIONAL DISTRESS. PER THE REPORT THE PATIENT'S FAMILY MEMBER PICKED UP THE PATIENT. THE FNP INSTRUCTED THE 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
    545693 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