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	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no previous complaints on this device.Device return requested.Device requested this mdr will be reopened and updated once the investigation results 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 10/04/2024, znyo medical received a report from the customer reporting a zyno pump had system error.No patient injury/harm reported.
Additional Manufacturer Narrative
This supplement serves as a correction.The reported failure mode has been assessed as not reportable.Our evaluation determined that the event did not pose a risk to the health of patients, users, or bystanders.Additionally, the report did not allege a serious injury or death, nor would the recurrence of the reported issue be expected to cause or contribute to a serious injury or death.Reference to complaint #(b)(4).
Additional Manufacturer Narrative
This supplement serves as a correction as part of our retrospective 2024 compliant remediation.Upon reassessment, the reported flow rate failure mode has been determined to be non-reportable.A pump system error alarm during infusion represents a severity 2- a minor injury to the patient or user that does not require professional medical intervention.Our evaluation concluded that the event did not pose a risk to the health of patients, users, or bystanders.Furthermore, the report did not allege a serious injury or death, nor would a recurrence of the reported issue be expected to cause or contribute to a serious injury or death.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: 20510698
• Report Number: 3006575795-2024-00994
• Device Sequence Number: 17894458
• Product Code: FRN
• UDI-Device Identifier: 00814371020037
• UDI-Public: 00814371020037
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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
• Operator of Device: Health Professional
• Device Model Number: Z800WF
• Device Catalogue Number: Z800WF
• Device Lot Number: 20160429-SH
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/19/2024; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2015
• 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