MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; 96" ADULT EXP,GSE,PAR WYE,(2)BV,LG.MASK,3LF BAG,3LF BAG,10'X.050" MM GSL,

Model Number 9677

Device Problems Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

Patient Problem Hypoxia (1918)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

The splitting of the tube caused the patient to become hypoxic.Based on this information the criteria for reporting an adverse event has been met.

Event Description

Splits in the tubing.This was discovered after the patient became hypoxic.

Manufacturer Narrative

The splitting of the tube caused the patient to become hypoxic.Based on this information the criteria for reporting an adverse event has been met.Complaint confirmed with the photos provided and returned goods.The root cause was determined to be that the hose that feeds one of the plastic resins into the blender was not properly connected.This resulted in an incorrect ratio of resins, leading to the tubing being more rigid and more likely to crack.Lab results confirmed that tubing manufactured after the hose was fixed was the correct ratio of plastic resins.We completed a health hazard evaluation as part of the risk assessment.The risk assessment performed with rma-20030 indicated a severity of 9.We initiated capa-00495 to address this issue.We reviewed the complaint history in our quality management system related to the affected product for the 24 months preceding the earliest complaint received.We did not receive any complaint for this product preceding complaint (b)(4).Also, we analyzed the frequency of complaints we have received for the circuit product family.There is no trending issue for the circuit product family.We emailed resolution to the customer.

Event Description

Splits in the tubing.This was discovered after the patient became hypoxic.

• Brand Name: WESTMED LLC
• Type of Device: 96" ADULT EXP,GSE,PAR WYE,(2)BV,LG.MASK,3LF BAG,3LF BAG,10'X.050" MM GSL,
• 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: 14597146
• MDR Text Key: 293349865
• Report Number: 2028807-2022-00015
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 00709078008290
• UDI-Public: 00709078008290
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9677
• Device Catalogue Number: 9677
• Device Lot Number: 122721T03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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