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 Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed on 12/12/2018.The flow rate was found to have a deviation of 174.04% which is out of +/- 5 % specification.Besides the reported issue, the pump was also found to have a dented keypad, and lcd display that was outside of specification, and a grinding door latch.In addition, the pump failed the pressure test and could not build pressure over 10 psi.It was deemed necessary that the pump should have the motor and peristaltic plate replaced.No repair was taken because the initial reporter denied the estimate.The pump periodic preventive maintenance (pm) interval recommended by zyno medical in the instructions for use (ifu) is one year.Our company records indicate that the last pm performed by zyno medical for this pump was on 04/22/2016.
Event or Problem Description
A distributor reported a free flow issue to zyno medical on (b)(6) 2018.The distributor received an email from the initial reporter on (b)(6) 2018, stating that the affected pump was free flowing during testing.No patient was involved.

• 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: 8178598
• Report Number: 3006575795-2018-00071
• Device Sequence Number: 1866761
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 20110204-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1