MAUDE Adverse Event Report: VYAIRE MEDICAL INC. MEDISORB; MULTI-ABSORBER ORIGINAL, DISPOSABLE

Model Number	M1173310
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: 4medisorb - absorber.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 03 jan 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or causes serious injury.
Event or Problem Description
During thoracic surgery case, anesthesiologist attempted to replace used sodasorb container as patient was starting to have increased inspiration of carbon dioxide which could be harmful during the surgery.Canister was replaced and could not ventilate or oxygenate patient.Canister removed and found to be cracked, used container. could not ventilate or oxygenate patient.
Event or Problem Description
During thoracic surgery case, anesthesiologist attempted to replace used sodasorb container as patient was starting to have increased inspiration of carbon dioxide which could be harmful during the surgery.Canister was replaced and could not ventilate or oxygenate patient.Canister removed and found to be cracked, used container.Could not ventilate or oxygenate patient.
Additional Manufacturer Narrative
H6: 4medisorb: absorber.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 03 jan 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint: (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or causes serious injury.This report is being withdrawn as the incident is registered under 3010838917, therfore it has been reported using report 3010838917-2025-00001.No further action will be reported under this mdr.

• Brand Name: MEDISORB
• Common Device Name: MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21073914
• Report Number: 8030673-2025-00001
• Device Sequence Number: 15610709
• Product Code: CBL
• UDI-Device Identifier: 10190752184329
• UDI-Public: (01)10190752184329
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M1173310
• Device Catalogue Number: M1173310
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 4100090000-2024-8017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown