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

Model Number	Z800
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 11/23/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 11/20/2020, and stated that pump# (b)(4) will not occlude.The device operator was a biomed technician.No medication was being infused.There was no patient involvement.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00046).
Additional Manufacturer Narrative
The service provider tested the device on 12/07/2020.The test report was received by zyno medical on 12/10/2020.The pump failed the pressure test.The pump occluded outside of the specification during the pressure test.The reported issue was confirmed.The pressure sensor was replaced.The pump was repaired and tested to meet full specifications.

• 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
• MDR Report Key: 10978849
• Report Number: 3006575795-2020-00046
• Device Sequence Number: 16954102
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: distributor,other,user facili
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2020

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: Z800
• Device Catalogue Number: Z-800
• Device Lot Number: 20120612-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1