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 Codes	Split (2537); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the affected iv set on 02/17/2017.The returned iv set is being sent to the contract supplier for evaluation.The manufacturer will actively follow up on this investigation.
Event or Problem Description
The user reported that "we went to infuse a patient with tysabri on one of our zyno pumps.The pump set had a split in the actual tubing and the medication spilled out on the floor of the clean room." on the follow-up call with a zyno customer service employee, the customer mentioned that the iv set was leaking in the mixing room and was never placed in the pump.No patient injury or harm occurred for this incident.
Additional Manufacturer Narrative
The user reported issue was confirmed.The iv set was evaluated by zyno medical and was found to have a split-tubing due to manufacturing defect.Details of the testing can be found in the report.A quality alert has been sent to the contract manufacturer on 04/13/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00051).

• 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: 6358440
• Report Number: 3006575795-2017-00051
• Device Sequence Number: 985025
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• 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): 04/10/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: A2-80072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1