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

Model Number	A2-80070
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is waiting for the arrival of the failed iv sets.
Event or Problem Description
The user reported a leaking issue with iv sets from the green vent valve."we infuse primarily biologic medications.The issues have happened on various different products, each running at different rates.We've had a number of instances where the set started leaking while trying to prime the set prior to starting an infusion.Some have leaked after the infusion starts and then others have started leaking three hours into a patient's infusion".No patient harm or injury was involved in this case.
Additional Manufacturer Narrative
The user reported issue was duplicated with one out of ten unopened iv sets from the same lot number.The failed iv set was sent to the contract supplier for further investigation on 04/14/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00076).

• 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: 6432749
• Report Number: 3006575795-2017-00076
• Device Sequence Number: 16271422
• Product Code: FPA
• UDI-Device Identifier: 00814371020051
• UDI-Public: 00814371020051
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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: A2-80070
• Device Lot Number: 1606002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1