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	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/03/2024, znyo medical received a report from the customer reporting that when they had an infusion the pump needed service as it is giving them a system error when they were trying to use it.No patient injury/harm reported.
Additional Manufacturer Narrative
Device return requested.There are no previous complaints on this device related to this issue.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).
Additional Manufacturer Narrative
Upon reassessment, the reported system error failure mode has been determined to be non-reportable.It was determined that events involving a system error alarm during infusion are not reportable.The occurrence of system error represents a severity of 2 - minor injury to the patient or user not requiring professional medical intervention.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: 20502336
• Report Number: 3006575795-2024-00970
• Device Sequence Number: 8221949
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 201016280
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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