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); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device return requested.There are no previous complaints on this device.The complaint will be reopened and updated in the event the device involved or additional information becomes available.A follow-up mdr will be submitted in the event additional information becomes available.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint # (b)(4).
Event or Problem Description
On 10/10/2024, znyo medical received a report from a customer reporting they were getting occlusion alarms on the pump.No patient harm/injury reported.
Additional Manufacturer Narrative
After consultation with the vp of medical affairs, during our mdr safety review meeting on october 31, 2024, it was determined that events involving a constant occlusion alarm when no occlusion exists are not reportable.The severity of this failure is 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: 20541678
• Report Number: 3006575795-2024-01019
• Device Sequence Number: 12719679
• Product Code: FRN
• UDI-Device Identifier: 00814371020037
• UDI-Public: 00814371020037
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: Health Professional
• Device Model Number: Z800WF
• Device Catalogue Number: Z800WF
• Device Lot Number: 191105292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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