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	Connection Problem (2900); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user-reported issue was not confirmed.The pump was found to connect with wireless system as intended.The pump also had a flow rate accuracy of -6.67% which is outside of the +/-5% specification.The pump was recalibrated and tested to meet all specifications on 02/02/2017.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer.During the final review of the complaint file by quality/management, it was determined as mdr reportable on 02/03/2017.
Event or Problem Description
A zyno product manager reported that two pumps would not connect to the wireless system for patient query and need to be replaced.This function was used prior to an infusion, so no infusion had started.No patient was involved in this case.

• 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: 6331302
• Report Number: 3006575795-2017-00046
• Device Sequence Number: 1518382
• 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): 02/10/2017

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: 01/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1