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); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently waiting for the device to arrive.
Event or Problem Description
The user reported that pump was over-infusing."pump did not infuse correctly.Approximately 30 minutes before the bag was empty.Yes pt was involved, the infusion was running into his vein, no injury." no patient injury or harm occurred in this case.
Additional Manufacturer Narrative
The device was tested at the client's site on 07/26/2017 and was found to meet all specifications.The flow rate had a calibration offset of 12% and was changed to 9%, and the final flow rate accuracy deviation was found to be -0.09%, which was within +/-5% specification.Zyno medical was unable to confirm the complaint.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00249).

• 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: 6747606
• Report Number: 3006575795-2017-00249
• Device Sequence Number: 210795
• 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): 08/17/2017

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: 20121213-SH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1