MAUDE Adverse Event Report: SUNSET HEALTHCARE SOLUTIONS, INC. SUNSET HEALTHCARE SOLUTIONS VC1001 CIRCUITS; TUBING, PRESSURE AND ACCESSORIES

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2024 potential chemical exposure from ventilator circuits.I need help to determine what to do about a potential chemical exposure.I have recently received "circuits" (hoses that connect the ventilator to the face mask).They have a strong odor.I even smell the odor when the unopened packages are in the same room.When using the ventilator there is a strong smell in the face mask after 15 min of use.Since the odor is objectionable, there is a real danger that it may be a health hazard and i have refused to use the circuits.I am using up the supply of older (no odor) circuits and will run out in the next few months.I believe the odor is from the pvc plasticizer used to make the hose and have returned an unopened sample to the manufacturer.The vendor (sunset healthcare solutions) replied: "our qa team evaluated the returned unopened package and found the product met our standards.In addition, biocompatibility test reports show that the product does not affect the in vitro cytotoxicity due to the quantitative and qualitative analyses based on the criteria set out by iso protocols." this response does not fill me with confidence.What chemical and what concentration is safe to breath for eight plus hours a night for the rest of my life? how do we know? besides, i find just the odor objectionable.For many years in the past, i used circuits manufactured by philips in germany and also in the usa and did not detect the odor.Recently philips stopped making the circuits.The smelly circuits were purchased by lincare (my ventilator servicer) from a new vendor, sunset healthcare solutions, and the package indicated it was manufactured.In turkey.I have an unopened package with a circuit in it.The unopened package has the smell.I am a retired phd chemist with 30 yr experience in the plastic industry.Pvc plasticizers are under intense scrutiny.I cannot identify the chemical by odor.What can be done to determine if there is a potential problem? what can be done to make sure that no one is harmed by this type of product? (b)(6).

• Brand Name: SUNSET HEALTHCARE SOLUTIONS VC1001 CIRCUITS
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): SUNSET HEALTHCARE SOLUTIONS, INC.
• MDR Report Key: 18545061
• MDR Text Key: 333389346
• Report Number: MW5150553
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention