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	Excess Flow or Over-Infusion (1311); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the device.
Event or Problem Description
A user facility representative reported an over-infusion issue to zyno medical on (b)(6) 2018: "the pump was set for 30 min and infused the patient in 13 min.The patient was not harmed and is okay".No information on solution being infused at the time of the event.The issue was first noticed on (b)(6) 2018 and the affected pump had not been used since then.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00057).
Additional Manufacturer Narrative
The pump was evaluated on 08/21/2018.The reported over-infusion issue was not confirmed.The pump was found to be under-infusing with a flow rate accuracy of -5.96%, which was outside of +/-5% specification.The pump was tested, recalibrated and met full specification.

• 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: 7740958
• Report Number: 3006575795-2018-00057
• Device Sequence Number: 16423591
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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: 20130227-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1