MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS; WARMER, THERMAL, INFUSION FLUID

Catalog Number 980202EU

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

Sample has been received and is in the process of being evaluated.Once the evaluation is finished a follow up report will be filed.

Event Description

Under investigation customer reported via email: leaking of the 3-inch pigtail when used in conjunction with the enflow® cartridge.No patient injury reported.The connection to the extension tubing that connects to the filter did not connect well when the infusion was started, and it began to leak.The rn's have not noted any difficulty connecting the filer with the extension tubing-detected when the machine run is initiated.Device was in use when leak was identified.No medical intervention was needed.The solution being infused was blood product.They have kept the product aside.

Manufacturer Narrative

The cartridge and extension were inspected.After inspecting the extension, it was noticed that the threads on the male lock were deformed.The root cause is a supplier molding issue resulting in the damaged leur lock on the extension set.At this time further investigation is ongoing with our supplier under scar1507.

• Brand Name: CARTRIDGES, W/ 3" EXT SET, ENFLOW, 30/CS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan 53262 0; CH 532620
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 6979652
• MDR Text Key: 90323576
• Report Number: 2050001-2017-00084
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 980202EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention