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

Model Number	B2 70071-P
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The failed iv set is being sent to the contract supplier for evaluation.A quality alert has been sent to the contract supplier on 01/18/2017 regarding this issue.
Event or Problem Description
The user experienced a pinch clamp leakage problem.This is a ltc (long term care) pharmacy.The issue was discovered at pharmacy during routing testing.During routine pump testing, 2 tube sets showed evidence of leaking through closed clamps-one while threaded in a pump (top clamp only), one while hanging attached to liter bag (both upper & lower roller clamps engaged).Over the course of several hours, all fluid in both source bags slowly leaked past the clamps and the bags emptied.This was after the pump test was completed but the tubing was still attached to source bags.Test was with 1000ml bags of ½ ns (normal saline).No patient was involved in the event.
Additional Manufacturer Narrative
Zyno medical has received the investigation report from the contract manufacturer on 04/25/2017.The user-reported complaint was not confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00027).

• 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: 6304813
• Report Number: 3006575795-2017-00027
• Device Sequence Number: 19022535
• Product Code: FPA
• UDI-Device Identifier: 00814371020181
• UDI-Public: 00814371020181
• 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): 04/28/2017

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 Expiration Date: 10/01/2019
• Device Model Number: B2 70071-P
• Device Lot Number: 16105224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1