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

Model Number	B2-70072-F
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	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The failed iv sets have been sent to the contract supplier for evaluation on 12/09/2016.The manufacturer is still waiting for the results.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer.During the final review of the complaint file by quality/management, it was determined as mdr reportable on 01/05/2017.
Event or Problem Description
The user reported a filter burst issue during flushing.The users were using orencia on the patient and were flushing the solution when the medicine was almost done.The filter burst and they used only 10cc of the saline solution.Patient was involved when incident was noticed.No injuries or harm occurred to the patient.Pump was set for 200ml/hr for 140ml.The iv set was being flushed at 200ml/hr with saline.
Additional Manufacturer Narrative
Zyno medical has received an initial investigation report from the contract supplier on 05/16/2017 and a follow-up investigation report with additional information on 06/06/2017.The user-reported filter burst issue has been confirmed and complaints for all models using this filter were reviewed.This complaint is considered as an isolated case and no additional complaint is found.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00012).

• 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: 6258238
• Report Number: 3006575795-2017-00012
• Device Sequence Number: 19083544
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/06/2017

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: B2-70072-F
• Device Lot Number: 16087537
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• 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