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 Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The failed iv sets have been sent to the contract supplier for evaluation on 01/03/2017.A quality alert has been sent to the contract supplier to address the issue proactively on 01/03/2017.The manufacturer will follow up on the investigation.
Event or Problem Description
The user reported the following information: "patient set up with an iv of taxol with the zyno pump.· infusion line was leaking, leaking came from the green vent; this was still apparent when brought into the pharmacy for our inspection; tubing was replaced with a second set.· emergency drugs were iv push and done at the lower port.· taxol was disconnected.This was to prevent any more taxol from accidentally infusing.· a second set was opened.This was the second set of tubing.The lower y site, that is part of the huber needle set up (this is where the taxol filter tubing was connected) did not break, the taxol filter tubing broke off into the actually luer lock of the y site causing the blue accordion to remain compressed so when emergency meds were given, it leaked out of this y site.Therefore a new iv (port access) had to be started." no patient injury or harm was involved in this event.The user reported a leaking issue from the air vent of zyno's iv set.
Additional Manufacturer Narrative
Zyno medical received the investigation report from the contract supplier on 06/05/2017.The user-reported leaking issue is confirmed.Corrective actions have been taken to address the manufacturing deficiency identified.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00011).

• 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: 6244135
• Report Number: 3006575795-2017-00011
• Device Sequence Number: 930011
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: 1410004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1