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	Device Alarm System (1012); Calibration Problem (2890); Infusion or Flow Problem (2964); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/17/2024, znyo medical received a report that during the preventive maintenance (pm), the air in line alert popped up multiple times during the pressure test.No patient injured/harmed reported.
Additional Manufacturer Narrative
A review of historical service test records was performed.It was confirmed that there were no service events that would cause or contribute to the reported failure.Complaint history was reviewed, there are no other air-in-line complaints reported on this device.During functional testing, the reported issue was not duplicated.There was no constant air-in-line alarm during the investigation.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
After consultation with the vp of medical affairs, during our mdr safety review meeting on december 4, 2024, it was determined that events involving constant air in line alarm when no air in line is present is not reportable.The occurrence of constant air in line alarm represents a severity of 1 - inconvenience or temporary discomfort.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.Therefore, 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 01760
• 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: 20584940
• Report Number: 3006575795-2024-01036
• Device Sequence Number: 18349851
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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
• Device Model Number: Z800WF
• Device Catalogue Number: Z800WF
• Device Lot Number: 201208256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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