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); Excess Flow or Over-Infusion (1311); Calibration Problem (2890); Device Sensing Problem (2917); Infusion or Flow Problem (2964); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/22/2024, znyo medical received a report that during the preventive maintenance (pm), they received a pressure test failure and a flowrate rate issue during testing.No patient involved reported.
Additional Manufacturer Narrative
There are no previous complaints on the device related to the issue.This pump underwent routine maintenance testing where it was detected the pump's performance fell outside the acceptable range for the flowrate % and they were getting a post error code.Consequently, it necessitated an adjustment to the pump's flowrate %.It was confirmed the recalibration replacement of the battery addressed the issue successfully.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
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.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.

• 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: 20636447
• Report Number: 3006575795-2024-01078
• Device Sequence Number: 7443196
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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: 20160402-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/18/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2014
• 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: Prefer Not To Disclose