MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Skin Discoloration (2074); Vomiting (2144)

Event Date 11/19/2021

Event Type  Injury  

Event Description

On 02/03/2022, zyno medical received a letter from fda (mw5106399).A nurse contacted fda on 12/28/2021 and reported that: "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 1 mg 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)." the event was reported as "adverse event without identified device or use problem".The device operator was a registered nurse.Medication being infused was inflectra.The patient had symptoms of chest pain, dyspnea, allergic reaction, skin discoloration and vomiting.

Manufacturer Narrative

Zyno medical has contacted the end user to follow up for more information and is still waiting for response.

Manufacturer Narrative

Zyno medical has contacted the end user to follow up for more information and is still waiting for response.

Event Description

On 02/03/2022, zyno medical received a letter from fda (mw5106399).A nurse contacted fda on 12/28/2021 and reported that: "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 1 mg 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)." the event was reported as "adverse event without identified device or use problem".The device operator was a registered nurse.Medication being infused was inflectra.The patient had symptoms of chest pain, dyspnea, allergic reaction, skin discoloration and vomiting.

Manufacturer Narrative

Zyno medical contacted the end user regarding the device return status on 02/04/2022, 02/09/2022 and 02/25/2022 by email and phone calls.No response was received from the end user.The affected device was not returned for evaluation.No investigation could be performed.No root cause could be established.

Event Description

This is a follow-up for the initially filed mdr.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Type of Device: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760
• MDR Report Key: 13536322
• MDR Text Key: 286241020
• Report Number: 3006575795-2022-00002
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization