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

Model Number	Z-800F
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuvie received a report indicating that an infusion pump failed the 30psi occlusion test, recording a pressure of 16psi which is outside the acceptable range of 22 to 38 psi.A review of the device's serial number history revealed no similar complaints.The failure mode was confirmed, and the probable cause was determined to be an out-of-calibration condition.The issue was successfully resolved by recalibrating the 30psi calibration value from 262 to 232.The occlusion failure was identified and corrected during servicing performed by a third-party service provider.Capa-zm2023-23 was initiated to investigate the root cause for this failure mode.Reference to complaint#: (b)(4).
Event or Problem Description
Intuvie received a report indicating that an infusion pump failed the 30psi occlusion test, recording a pressure of 16psi which is outside the acceptable range of 22 to 38 psi.No patient involvement was reported.

• 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 ; 5086502008
• MDR Report Key: 22827767
• Report Number: 3006575795-2025-00350
• Device Sequence Number: 4463596
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: Z-800F
• Device Catalogue Number: Z-800F
• Device Lot Number: 2403121000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2024
• 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
• Patient Sex: Unknown