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

Model Number	A2-80072
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	12/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still waiting for the arrival of the unopened iv sets from the same lot #.A quality alert has been sent to the contract supplier on 01/10/2017.The manufacturer will follow up with the investigation actively.
Event or Problem Description
The user reported that "we hang a primary bag of iv fluids dropped down with 2 extensions from the iv pole.The primary bag tubing threads through the pump.Our bags with chemo are piggy backed at the top port.Even with the primary bag dropped low, the tubing fed correctly, setting properly entered, the chemo bag is back filling into the primary bag.This should not happen and we have not had this issue with any other pump we have used".This happened during patient treatment but no injury or harm of the patient was involved."it happened 7 or 8 times over the last 3 days." the failed iv sets were not saved.The reported iv sets potentially had a back check valve issue.
Additional Manufacturer Narrative
The user-reported issue that fluid was back-filling into the primary bag could not be confirmed.The user contacted zyno customer service on 03/27/2017 that no affected iv sets was available to be sent to zyno for evaluation.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00006).

• 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: 6304672
• Report Number: 3006575795-2017-00006
• Device Sequence Number: 58292
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (Y/N): N
• 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): 03/28/2017

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: A2-80072
• Device Lot Number: 16087971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1