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	Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is waiting for the arrival of the pump.
Event or Problem Description
The user reported that the pump was underinfusing."it took 45 minutes to infuse benadryl at the rate of 300 ml/hr for an 100 ml bag.It was being used on a patient.It just took longer to infuse." no patient injury or harm occured for this case.
Additional Manufacturer Narrative
The user-reported under-infusing issue cannot be confirmed.The device had a flow rate accuracy of 12.15%, which was outside of the +/-5% specification and was an over-infusing issue.The device also failed the 30 psi occlusion test; this issue was not related to the user-reported issue.The device was recalibrated, repaired, and tested to meet all specifications on 08/21/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00236).

• 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: 6675041
• Report Number: 3006575795-2017-00236
• Device Sequence Number: 44408
• 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): 09/15/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1