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

Model Number	Z800F
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/15/2024, zyno medical received a request from the customer stating they needed the hex file.Per the customer the pump calibrated the volume.No patient was involved as it was discovered during testing.
Additional Manufacturer Narrative
There is anothe rcomplaints on the device related to this issue.This pump underwent routine maintenance testing by a third-party service provider where it was detected the pump's performance fell outside the acceptable range for offset.Following this discovery, the end user requested a hex file to recalibrate the pump.As a result, it is determined that the device does not need to be returned for further evaluation, given that the recalibration has successfully addressed the issue.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint # (b)(4).
Additional Manufacturer Narrative
During routine preventive maintenance (pm) testing of the z-800wf infusion pump at (b)(6)(third party).The device was found to have failed the flow rate test.The pump was then shipped here so we could update the dhr to match the pump.A review of the device's serial number history revealed one similar complaint.Reference to complaint # (b)(4).
Additional Manufacturer Narrative
This supplement serves as a correction as part of our retrospective 2024 complaint remediation.Upon reassessment, flow rate failures +5% to + 15% or -5% to -15% would not lead to the harm of a patient.The reported flow rate failure mode has been determined to be non-reportable.The severity of this failure is 1 - inconvenience or temporary discomfort.Reportability assessment: our evaluation concluded that this complaint reported did not pose risk to health to patient, users or bystanders, did not allege a serious injury or death and would not cause or contribute to a serious injury or death if the reported issue recurred.This event is not reportable.Reference to complaint # (b)(4).

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 20549490
• Report Number: 3006575795-2024-01029
• Device Sequence Number: 19633338
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: Z800F
• Device Catalogue Number: Z800F
• Device Lot Number: 20150907-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/12/2024; Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/22/2024; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown