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

Model Number	Z-800W
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User reported issue was unconfirmed.Device was found to have a flow rate accuracy deviation of -0.17%, which is within the +/-5% specification.The device was found to have the air-in-line alarm not working.The device was repaired and retested to meet all the specifications on (b)(6) 2015.The initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.
Event or Problem Description
The user reported the pump was infusing slower than anticipated.No patient injury or harm was involved in this case.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOL. PERISTALTIC INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL LLC.; 177 pine street; natick MA 01760
• MDR Report Key: 6244007
• Report Number: 3006575795-2016-00065
• Device Sequence Number: 994134
• 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
• Report Date (Section B): 01/11/2017

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: 20120222-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2015
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1