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

Model Number	A2-80071-DF
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	04/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At zyno medical has received the investigation report from the contract supplier on (b)(6) 2017.The leaking issue at the green vent was confirmed.The root cause was identified that the improper welding process around the d8 air-screened membrane.Preventive actions were taken by the contract supplier and the details can be found in the attached report.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer by following the company procedures.This mdr is filed retrospectively filed as the investigation result falls constitute mdr reportable event according to the current internal mdr decision guidance at zyno medical.(b)(4).
Event or Problem Description
The user reported that they encountered a filter tubing leakage issue."today, we had a filter tubing leakage right at the base of the spike where the green air vent is.The vent was closed when leakage was noticed, but when the nurse investigated, she opened the green vent and noticed the leakage increased slightly.There was very little leakage, as it was caught quickly."there was no patient injury: "i can tell you the person sitting with the patient noticed within 15 to 20 minutes of infusion start.The patient was not harmed in any way, and there was very little leakage.I have just been informed that an incident like this happened at our georgetown site a while back.The patient was not harmed in that incident as well, but i do not have the tubing for that one to send you.In regards to the first incident the drug was called erbitux, but do not know any other information on that.Today's incident happened while infusing paclitaxel in 250mls of 0.9% sodium chloride.The infusion was running at 50ml/hr, when it occurred.The start time was 12:15, and it occurred approximately 15 to 20 minutes into the infusion.".
Additional Manufacturer Narrative
Upon receiving the complaint, it was initially determined as not reportable by the manufacturer by following the company procedures.This mdr is filed retrospectively filed according to the current internal mdr decision guidance at zyno medical.The mdr decision was made on (b)(6) 2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00273).

• 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: 6886158
• Report Number: 3006575795-2017-00273
• Device Sequence Number: 19022774
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/25/2017

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-DF
• Device Lot Number: 1410014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2016
• Supplement Date Received by Manufacturer: 04/11/2016
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1