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

Model Number	Z-800W
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the infusion pump.
Event or Problem Description
The user reported that the pump was overinfusing."i have 3 more pumps that are infusing too fast.Two of them infused 60 ml in 5 min at a rate of 200.A (b)(4) (sn)".No patient injury or harm occured for this case.
Additional Manufacturer Narrative
The user-reported issue was not confirmed.The device was found to have a flow rate accuracy of 0.98%, which was within the +/-5% specification.It was found to have a battery outside of warranty which was not related to the reported issue.The device was tested to meet all specifications on 07/17/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00124).

• 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: 6587617
• Report Number: 3006575795-2017-00124
• Device Sequence Number: 16323531
• Product Code: FRN
• UDI-Device Identifier: 00814371020020
• UDI-Public: 00814371020020
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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-800W
• Device Catalogue Number: Z-800W
• Device Lot Number: 20120612-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1