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	Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still in the process of testing the infusion pump. .
Event or Problem Description
The user reported that the pump's flow rate was off.No patient injury or harm occured in this case.
Additional Manufacturer Narrative
The user reported issue was not confirmed.The pump was found to have a flow rate accuracy of -4.54% which was within +/-5% specification.The pump was found to have a constant air-in-line-alarm and a battery outside of warranty issue, both of which were not related the reported issue.The pump was repaired and tested to meet all specifications on 05/09/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00098).

• 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: 6537096
• Report Number: 3006575795-2017-00098
• Device Sequence Number: 1643011
• 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): 05/11/2017

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 Lot Number: 20121213-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1