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

Model Number	Z800WF
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Calibration Problem (2890); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are previous complaints on the device not related to this issue.During routine maintenance testing, it was found that the pump's performance for flowrate % was below the acceptable range.An adjustment was made to recalibrate the flowrate % successfully resolving the issue.A corrective and preventive action (capa) has been initiated to investigate the root cause of this event, reference complaint #(b)(4).
Event or Problem Description
On 10/15/2024, znyo medical received a report that during the preventive maintenance (pm), the device was reported to have a flow rate offset issue.Failed flowrate test with a deviation of (b)(4).No report patient was involved.
Additional Manufacturer Narrative
This supplement serves as a correction.Upon further evaluation, it has been determined that this event does not meet the criteria to be classified as a complaint.The flow rate was within specifications.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: 20584922
• Report Number: 3006575795-2024-01104
• Device Sequence Number: 8827754
• Product Code: FRN
• UDI-Device Identifier: 00814371020037
• UDI-Public: 00814371020037
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/06/2025

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: Z800WF
• Device Catalogue Number: Z800WF
• Device Lot Number: 20170113-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• 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: Not provided; Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/19/2024; 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2016
• 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