MAUDE Adverse Event Report: ALLIED MEDICAL LLC. LITHOLYME; LITHOLYME, GE MULTI-STYLE CARTRIDGE

Model Number	55-01-0017
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following a thorough investigation, we have determined that the issue stemmed from the fit of the canister within the machine, rather than from any defect or quality issue with the absorbent material itself.To proactively address the compatibility concern, we have also initiated a project to revise the canister specifications, ensuring improved fit within the equipment and enhanced overall performance.
Event or Problem Description
As has been reported before, the anesthesia machine had a major leak halfway through a cardiac case.This is due to the co2 absorbers not being compatible with the anesthesia machines that divisional supply chain had decided to change without consultation of the anesthesia department.In this event the anesthesia gas flows had to be adjusted significantly until the patient was able to be on cardiopulmonary bypass so the machine could be changed out since the leak could not be checked and the machine could not be troubleshooted while a patient was actively connected to the machine.
Additional Manufacturer Narrative
Following a thorough investigation, we have determined that the issue stemmed from the fit of the canister within the machine, rather than from any defect or quality issue with the absorbent material itself.To proactively address the compatibility concern, we have also initiated a project to revise the canister specifications, ensuring improved fit within the equipment and enhanced overall performance.Supplemental to report # 1924066-2025-00074 added 11/20/2025 further communication with hospital staff member (b)(6), chief crna,on 11/11/2025, clarified that the procedure was a cardiac case in which the patient would have been placed on cardiopulmonary bypass as part of the planned course of surgery.After the procedure was completed, hospital staff confirmed that the leak originated from the co2 absorbent canister.Follow-up efforts were made to obtain device-specific identifying information (e.G., udi or lot number); however, no additional information was obtained, and the affected lot cannot be confirmed.The device was not returned for evaluation.There was no harm to the patient, and the procedure was completed as planned.According to the complainant, "this is due to the co2 absorbers not being compatible with the anesthesia machines that the divisional supply chain decided to change without consulting the anesthesia department.' based on this complaint and other related complaints, the design was updated to strengthen overall canister performance.The updated design builds on the proven performance of the original canister, increasing durability and ease of use, and the enhancements were informed by field data and customer feedback.
Event or Problem Description
As has been reported before, the anesthesia machine had a major leak halfway through a cardiac case.This is due to the co2 absorbers not being compatible with the anesthesia machines that divisional supply chain had decided to change without consultation of the anesthesia department.In this event the anesthesia gas flows had to be adjusted significantly until the patient was able to be on cardiopulmonary bypass so the machine could be changed out since the leak could not be checked and the machine could not be troubleshooted while a patient was actively connected to the machine.

• Brand Name: LITHOLYME
• Common Device Name: LITHOLYME, GE MULTI-STYLE CARTRIDGE
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 46 new street; stuyvesant falls NY 12174
• Manufacturer (Section G): ALLIED MEDICAL LLC; 46 new street; stuyvesant falls NY 12174
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; earth city, MO 63045 ; 3147712400
• MDR Report Key: 22900484
• Report Number: 1924066-2025-00074
• Device Sequence Number: 8931782
• Product Code: CBL
• UDI-Device Identifier: 00026072025260
• UDI-Public: (01)00026072025260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 55-01-0017
• Device Catalogue Number: 55-01-0017
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown