MAUDE Adverse Event Report: AIRLIFE OY 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
Report was initially reported with 8030673-2025-00001, which will be withdrawn as the device is registered with airlife oy.During thoracic surgery case, anesthesiologist attempted to replace used sodasorb container as patient was starting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 (b)(6)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.The complaint of "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 then replaced until anesthesia tech could bring replacement canister." regarding part m1173310 medisorb canisters was not confirmed.The root cause was not determined but could possibly be a result of use error: using cracked canister without leak test.Ifu states "make sure the connecting surfaces are free of dust; the multi-absorber is properly installed and the breathing circuit is checked for leakage and occlusion prior to use." most likely cause for cracked canister could be an extensive force at some point after 100% leak testing: like packaging, shipping, unloading, storaging, or installing.A risk assessment was performed, and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue sha-hl-0053-030 within the 24 months preceding this reported event.There have been (b)(4) prior complaints regarding the same part and leaking.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Report was initially reported with 8030673-2025-00001, which will be withdrawn as the device is registered with airlife oy.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 a second incident was discovered for the same issue, which was record in a separate complaint (b)(4) with mdr report 3010838917-2025-00002.

• Brand Name: MEDISORB
• Common Device Name: MULTI-ABSORBER ORIGINAL, DISPOSABLE,
• Manufacturer (Section D): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): AIRLIFE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21074757
• Report Number: 3010838917-2025-00001
• Device Sequence Number: 8386496
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: UNKNOWN
• 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: 02/10/2025
• 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: Initial
• 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