MAUDE Adverse Event Report: ZYNO MEDICAL, LLC Z-800F; PUMP, INFUSION

Model Number	Z-800F
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Intuvie received a voluntary medwatch form fda 3500 (mw5187474) report stating: ¿their infusion pump alarm didn't go off.Woke up with chest pains after falling asleep while being infused and went to the emergency room.Pump was given to the reporter on 2026.Z800 zyno infusion pump recalled 06-16-2025 due to air in line software defect.The pharmacy gave reporter a new brand of device with missing parts and told reporter to continue using old pump until the new pieces were provided.¿.
Additional Manufacturer Narrative
No reporter contact information was provided with the voluntary medwatch report.As a result, intuvie is unable to obtain additional information regarding the pump serial number, therapy being administered, event date, alarm history, whether air was observed in the line, emergency room diagnosis, treatment provided, or device availability for return and evaluation.Reference to complaint#: (b)(4).

• Brand Name: Z-800F
• Common Device Name: PUMP, INFUSION
• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 25434080
• Report Number: 3006575795-2026-01229
• Device Sequence Number: 16029676
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: Z-800F
• Device Catalogue Number: Z-800F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female