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

Model Number	Z-800
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump was tested with the following protocol: connect tubing into reservoir.Prime tubing by gravity, then connect tubing to pressure gauge.Test 1: turn on the pump fail test if pump displays "pressure error" on post test 2: set prog to 125ml/hr for 20 vtbi, go to biomed options and set pressure to 8 psi.Run pump, pass pump if it alarms between 0 and 16 psi.Test 3: set prog to 125ml/hr for 20 vtbi, go to biomed options and set pressure to 30 psi.Run pump, pass pump if it alarms between 22 and 38 psi.Pump passed all 3 tests with no false or constant occlusion alarms.Pressure gauge s/n: (b)(6) cal date: on (b)(6) 2023.Reported issues is not confirmed.Pump meets passing criteria.Pump is being scrapped since it has reached end of life.
Event or Problem Description
On (b)(6) 2022 zyno solutions received an email stating that pump (b)(6) was returned to her and it had a note on the pump that stated "occlusion." operator rn.Medication n/a.Patient involved.Patient was not harmed.Event date is unknown.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP
• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 18842327
• Report Number: 3006575795-2024-00039
• Device Sequence Number: 12566696
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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: Health Professional
• Device Model Number: Z-800
• Device Lot Number: 20130123-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: 12/06/2022
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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