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); Infusion or Flow Problem (2964); Pressure Problem (3012)
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 device had failed the 30 psi and the flowrate test.30 psi test failed at 43, with a maximum allowable value of 38 and the flow rate was adjust it close to a 5% deviation, no patient was involved.
Additional Manufacturer Narrative
Recent complaints regarding the device highlighted issues with a pump that underwent routine maintenance testing by "intuvie." during testing, it was found that the pump's occlusion psi value was too high at 43, exceeding the acceptable threshold for the 30 psi.Additionally, the flow rate deviation was recorded at 5% surpassing the standard tolerance of 4.5%.To address these issues, the pump was calibrated, which successfully resolved the identified problems.A corrective and preventive action (capa) has been initiated to investigate the root cause of the reported event.Reference: 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).

• 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: 20584997
• Report Number: 3006575795-2024-01032
• Device Sequence Number: 18199520
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2024

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: 191105292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• 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: 11/01/2024
• Supplement Report FDA Received Date: 11/17/2024
• 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: Prefer Not To Disclose