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

Model Number A2-80072

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is still waiting for the arrival of the affected iv sets.

Event Description

The user reported that the iv sets were leaking from bottom of drip chamber.No patient was involved in this case.

Manufacturer Narrative

The manufacturer received the investigation report from its contract supplier on 09/12/2017.The leaking issue was confirmed.The root cause was due to inadequate adhesion process performed between the drip chamber and the hose.The re-training of the operation personnel at the contract supplier site has been enforced on 05/16/2017 to address similar reported issues.(b)(4).

Event Description

This is a follow-up for the initially filed mdr (3006575795-2017-00073).

• 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 (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 6432712
• MDR Text Key: 70909663
• Report Number: 3006575795-2017-00073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• 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
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

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 Model Number: A2-80072
• Device Lot Number: 1604008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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