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

Model Number	Z-800
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was tested by the service provider on 04/05/2019.The flow rate deviation was within the +/- 5% specification.The pump met all specifications as intended.The reported issue was not confirmed.
Event or Problem Description
On (b)(6) 2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 03/14/2019, and stated that one of her nurses was infusing saline, and the time that was set was different from the actual amount of time the infusion took.She stated there was no one harmed.She stated the assumption is that the time is slower by 30 min than it should be.Event date was not provided.

• 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: 10650046
• Report Number: 3006575795-2020-00024
• Device Sequence Number: 3216122
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Y
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: Health Professional
• Device Model Number: Z-800
• Device Catalogue Number: Z-800
• Device Lot Number: 160713322
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1