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
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Splits in the tubing.This was discovered after the patient became hypoxic.
Additional 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 or Problem Description
Splits in the tubing.This was discovered after the patient became hypoxic.

• Brand Name: WESTMED LLC
• Common Device Name: 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
• Report Number: 2028807-2022-00015
• Device Sequence Number: 5530304
• Product Code: OFP
• UDI-Device Identifier: 00709078008290
• UDI-Public: 00709078008290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown