MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number	Z800F
Medical Device Problem Codes	Device Alarm System (1012); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Calibration Problem (2890); Infusion or Flow Problem (2964); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are no previous complaints on the device.This pump underwent routine maintenance testing by "intuvie" provider where it was detected the pump had constant air-in-line alarms.The flow rate testing failed due to a 10.32% deviation, which does not meet the standard rate of +/- 4.5%.Replacing the air-in-line sensor and the recalibration of the flowrate from 6 to -4 confirmed to have successfully addressed the issues.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 10/15/2024, znyo medical received a report that during the preventive maintenance (pm), the pump had constant air-in-line alarms and the flow rate testing failed due to a 10.32% deviation, which does not meet the standard rate of +/- 4.5%.No patient injury/harm reported.

• 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: 20551026
• Report Number: 3006575795-2024-01024
• Device Sequence Number: 8996365
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: Z800F
• Device Catalogue Number: Z800F
• Device Lot Number: 20120612-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2013
• 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