MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP; IV ADMINISTRATION SET

Model Number	B2-70071-P
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	Not Applicable (3189)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is still waiting for the arrival of the device.
Event or Problem Description
A certified pharmacy technician at the user facility reported an over-infusion issue to zyno medical on (b)(6) 2018.The incident occurred during routine post cleaning pump testing on (b)(6) 2018 and involved a b2-70071-p primary tubing set and a z-800f infusion pump.No patient was involved in this case.The following was reported from the initial reporter: "i need to report a flow failure of a zyno primary tube set part # b2-70071-p lot# 16117996 exp 11-27-2019 properly installed in a z800-f pump on our test bed unit was set to run 250 ml @ 167 ml / hour should have taken 1 hour 30 minutes to complete bag emptied in under 30 minutes i have verified proper installation and set- up of the pump a second unit set up identically with the same tubing set started at the same time - appears to be running properly i have the packaging and the tube set with the iv bag attached if you would like to collect it for testing please let me know as i am very concerned about this we had a run of similar tube failures before - and while: to my knowledge so far this has not had patient impact.The potential for harm is very clearly evident in this product failure" zyno medical followed up with the initial reporter on (b)(6) 2018 and obtained the response that "yes i have the pump segregated just in case it was somehow at fault sn is 613468".The initial reporter also confirmed the event date and patient involvement: "no patient was involved - fortunately this was discovered during routine post cleaning pump testing in-house in the pharmacy the issue was discovered today (b)(6) 2018: shortly before i sent you the email".This mdr addresses the b2-70071-p primary tubing set involved in this incident.The contract supplier for the affected infusion tubing set is becton dickinson.
Additional Manufacturer Narrative
The administration set was not returned to zyno medical for investigation.Thus, the reported flow rate issue could not be confirmed with the administration set.The infusion pump associated with the complaint was evaluated and was found to have a flow rate of -2.58%, which was within the +/-5% specification.This investigation result was reported under mdr #3006575795-2018-00027 on 03/12/2018.This administration set complaint was closed on (b)(6) 2018.
Event or Problem Description
This is a follow up report for the initially submitted mdr (3006575795-2018-00028).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7283544
• Report Number: 3006575795-2018-00028
• Device Sequence Number: 1176915
• Product Code: FPA
• UDI-Device Identifier: 00814371020181
• UDI-Public: 00814371020181
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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 Expiration Date: 11/01/2019
• Device Model Number: B2-70071-P
• Device Catalogue Number: B2-70071-P
• Device Lot Number: 16117996
• 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: 02/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1