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

Model Number B2 70071-P

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 01/04/2017

Event Type  malfunction  

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 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.

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 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
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC.; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 6304813
• MDR Text Key: 66679521
• Report Number: 3006575795-2017-00027
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020181
• UDI-Public: 00814371020181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1