MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; 72" ADULT UNI-LIM CIRCUIT, GSE W/TETHERED CAP, (2) B/V FILTERS, 10' X .050" ID M

Model Number 5610004

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

Circuits are inoperative: cracks in tubing, kinked and/or having holes.1 event occurred during use.Pt required bagging until circuit was replaced.1 event discovered during setup.Prior to pt use.

Manufacturer Narrative

The being cracked or kinked would disrupt the patient therapy.The clinician would need to replace the circuit during procedure causing an interruption in patient therapy.

Manufacturer Narrative

The being cracked or kinked would disrupt the patient therapy.The clinician would need to replace the circuit during procedure causing an interruption in patient therapy.The investigation confirmed the defect of damaged components based on the provided customer photos.The most likely root cause of the observed defect was identified to be the manufacturing and molding of the devices.A quality alert (24-036) has been issued to the manufacturing site as a result of these findings.

Event Description

Circuits are inoperative: cracks in tubing, kinked and/or having holes.1 event occurred during use.Pt required bagging until circuit was replaced.1 event discovered during setup.Prior to pt use.

• Brand Name: WESTMED LLC
• Type of Device: 72" ADULT UNI-LIM CIRCUIT, GSE W/TETHERED CAP, (2) B/V FILTERS, 10' X .050" ID M
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18548317
• MDR Text Key: 333493840
• Report Number: 2028807-2024-00002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5610004
• Device Catalogue Number: 5610004
• Device Lot Number: 433324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other