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

Model Number	A2-80071-D
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will be sending an unused sample tubing with the same lot number for evaluation.The manufacturer is still waiting for the arrival of the iv set.
Event or Problem Description
The user reported that an iv set had a leaking issue from the air vent: "when they are infusing gamma guard, they are opening the air vent on the drip chamber and solution is coming out of it.In addition, when they are infusing the gamma guard (from a glass bottle), the tubing becomes full of air and the amount of air in the length of the tubing segment of the pump.The air sensitivity on the pumps is set at the highest setting.The sensitivity of the pumps was set at.14 (ml).The highest setting." the associated pumps did alarm for air-in-line.No patient injury or harm occured in this case.
Additional Manufacturer Narrative
The manufacturer completed the testing on 07/05/2017 and was unable to duplicate the reported issue on an unopened iv set from the same lot.Zyno medical was unable to obtain the same solution (ivig solution) used when the user observed the air-in-line issue and thus used saline for the testing.Details of the test results can be found in the attached report.(b)(4).
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00222).
Additional Manufacturer Narrative
On (b)(6) 2017, zyno medical performed testing on 10 unused administration set from the same lot regarding the user-reported leaking issue at the air-vent of the administration set.No fluid leakage was observed from the air-vent of the administration set and thus the user-reported complaint could not be confirmed.Details of the testing can be found in the report attached.
Event or Problem Description
This is the second follow-up for the initially filed mdr (3006575795-2017-00222).

• 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: 6645288
• Report Number: 3006575795-2017-00222
• Device Sequence Number: 11025314
• Product Code: FPA
• UDI-Device Identifier: 00814371020068
• UDI-Public: 00814371020068
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 10/03/2017

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: A2-80071-D
• Device Lot Number: 1604005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2017
• Supplement Date Received by Manufacturer: 06/02/2017; 06/02/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/07/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1