MAUDE Adverse Event Report: AIRLIFE MEDISORB; MULTI-ABSORBER ORIGINAL, DISPOSABLE

Model Number	M1173310
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
There are granules getting past the filter and going inside the anesthesia machines and causing delays in patient care.Anesthesia machines are malfunctioning due to the dust from the sodasorb entering the breathing system.Delayed procedure and anesthesia machines repaired.
Additional Manufacturer Narrative
All information reasonably known as of 03 june 2025 has been included in this 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 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 caused serious injury.
Event or Problem Description
There are granules getting past the filter and going inside the anesthesia machines and causing delays in patient care.Anesthesia machines are malfunctioning due to the dust from the sodasorb entering the breathing system.Delayed procedure and anesthesia machines repaired.
Additional Manufacturer Narrative
All information reasonably known as of 03 june 2025 has been included in this 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 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 caused serious injury the complaint of "there are granules getting past the filter and going inside the anesthesia machines and causing delays in patient care.Anesthesia machines are malfunctioning due to the dust from the sodasorb entering the breathing system.Delayed procedure and anesthesia machines repaired." regarding part m1173310 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been no other complaints regarding the same part and a similar issue since 18nov2024 manufacturing release preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: MEDISORB
• Common Device Name: MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): AIRLIFE; 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: 22137579
• Report Number: 1314417-2025-00036
• Device Sequence Number: 7122903
• Product Code: CBL
• UDI-Device Identifier: 10190752184329
• UDI-Public: (01)10190752184329(10)0004309031
• Combination Product (Y/N): N
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 0004309031
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown