AEROGEN SOLO ADULT T-PIECE 22MM
Report
- Report Number
- 3003399703-2025-22731
- Event Type
- Malfunction
- Date Received
- June 24, 2025
- Date of Event
- April 21, 2025
- Report Date
- May 26, 2025
- Manufacturer
- AEROGEN LTD
- Product Code
- CAF
- PMA / PMN Number
- K070642
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
" SHATTERED" AEROGEN T-PIECE IN MEXICO." THIS IS BEING INVESTIGATED AS A NON-RETURN. THE DEVICE REPORTED WAS NOT RETURNED TO AEROGEN FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER AND THERE WAS INSUFFICIENT EVIDENCE/INFORMATION SUPPLIED BY THE CUSTOMER TO DETERMINE A ROOT CAUSE. RISK REVIEW THE AVAILABLE EVIDENCE INDICATES THAT NO SERIOUS HARM/INJURY OR IMPACT TO THE PATIENT OCCURRED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR THESE CASES, IT CAN BE DETERMINED THAT THE ROOT CAUSE OF THE COMPLAINT IS THE ADVERSE EFFECTS ON THE CONSTITUENT PLASTICS OF THE T-PIECE WHEN USED FOR VOLATILE ANESTHETIC DELIVERY. THERE IS AN ONGOING IMPROVEMENT INITIATIVE (PROJECT BUNDORAN) AIMED AT ENHANCING THE DURABILITY OF THE T-PIECE, IT IS IMPORTANT TO NOTE THIS INITIATIVE WAS PROACTIVELY IDENTIFIED AND INITIATED INDEPENDENTLY OF ANY RECEIVED COMPLAINTS. AS SUCH, THIS INITIATIVE REPRESENTS AN IMPROVEMENT ACTION, NOT A DIRECT CORRECTIVE ACTION IN RESPONSE TO THESE COMPLAINTS. NEVERTHELESS, WE ACKNOWLEDGE THAT SUCCESSFUL COMPLETION OF THIS PROJECT MAY INDIRECTLY REDUCE THE IDENTIFIED RISK CLINICAL REVIEW BASED ON THE VERY LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE PROBLEM APPEARS TO BE MATERIAL INCOMPATIBILITY[?]SPECIFICALLY THE USE OF POLYCARBONATE-BASED COMPONENTS (T-PIECES OF THE AEROGEN® SOLO SYSTEM) WITH VOLATILE ANAESTHETICS LIKE ISOFLURANE IN UNVALIDATED SYSTEM CONFIGURATIONS. ALTHOUGH NO DIRECT PATIENT HARM WAS REPORTED IN THESE INCIDENTS, THE PRESENCE OF CRACKS IN THE AEROGEN® SOLO T-PIECES RAISES IMPORTANT SAFETY CONSIDERATIONS. GIVEN THE STANDARDISED SETUP PROPOSED BY SEDANA MEDICAL IN THEIR IFU, SUCH CRACKS/ FRACTURES OCCURRED IN THE GAS PATHWAY NEAR THE PATIENT'S AIRWAY/ FACE. THIS POSES A POTENTIAL RISK OF ASPIRATION OF FOREIGN MATERIAL/ FRAGMENTS AND/OR DISRUPTION TO THE VENTILATOR CIRCUIT AND OUTGASSING. CLINICAL SUMMARY VERY LIMITED INFORMATION HAS BEEN PROVIDED WITH WHICH TO UNDERTAKE THESE ASSESSMENTS. FIVE AEROGEN® T-PIECES HAVE REPORTEDLY FRACTURED/ CRACKED, MOST LIKELY DUE TO EXPOSURE TO ISOFLURANE. IT IS WELL DOCUMENTED THAT VOLATILE ANAESTHETIC AGENTS, SUCH AS ISOFLURANE, ARE CORROSIVE TO CERTAIN MATERIALS, INCLUDING POLYCARBONATE. IN THESE CASES, THE ROOT CAUSE APPEARS TO BE MATERIAL INCOMPATIBILITY[?]SPECIFICALLY, THE USE OF POLYCARBONATE-BASED COMPONENTS (I.E. AEROGEN® SOLO T-PIECES) IN SYSTEM CONFIGURATIONS INVOLVING VOLATILE ANAESTHETICS (ISOFLURANE) THAT HAVE NOT BEEN VALIDATED BY THE AEROGEN IMDRF CODES. F15 - RECOGNISED DEVICE OR PROCEDURAL COMPLICATION MAY BE APPLICABLE - MATERIAL INCOMPATIBILITY BETWEEN VOLATILE ANAESTHETICS AND POLYCARBONATE COMPONENTS IS A KNOWN ISSUE, AS DOCUMENTED IN LITERATURE AND INSTRUCTIONS FOR USE (IFUS). MULTIPLE REPORTS AND MANUFACTURER WARNINGS CITE THE WELL-ESTABLISHED RISK OF STRESS CRACKING OR DEGRADATION WHEN VOLATILE ANAESTHETICS (ESPECIALLY ISOFLURANE) CONTACT POLYCARBONATE. HENCE, CRACKING OR BREAKING OF COMPONENTS IN THIS CONTEXT IS A RECOGNISED COMPLICATION OF INAPPROPRIATE MATERIAL COMPATIBILITY. F26 - NO HEALTH CONSEQUENCES OR IMPACT IN THIS INSTANCE NO PATIENT HARM OR IMPACT WAS REPORTED. E2403 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS THE INFORMATION AVAILABLE FOR REVIEW STATES NO PATIENT IMPACT.
"SHATTERED" AEROGEN T-PIECE IN MEXICO." THIS IS BEING INVESTIGATED AS A NON-RETURN. THE DEVICE REPORTED WAS NOT RETURNED TO AEROGEN FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER AND THERE WAS INSUFFICIENT EVIDENCE/INFORMATION SUPPLIED BY THE CUSTOMER TO DETERMINE A ROOT CAUSE. RISK REVIEW: THE AVAILABLE EVIDENCE INDICATES THAT NO SERIOUS HARM/INJURY OR IMPACT TO THE PATIENT OCCURRED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR THESE CASES, IT CAN BE DETERMINED THAT THE ROOT CAUSE OF THE COMPLAINT IS THE ADVERSE EFFECTS ON THE CONSTITUENT PLASTICS OF THE T-PIECE WHEN USED FOR VOLATILE ANESTHETIC DELIVERY. THERE IS AN ONGOING IMPROVEMENT INITIATIVE (PROJECT BUNDORAN) AIMED AT ENHANCING THE DURABILITY OF THE T-PIECE, IT IS IMPORTANT TO NOTE THIS INITIATIVE WAS PROACTIVELY IDENTIFIED AND INITIATED INDEPENDENTLY OF ANY RECEIVED COMPLAINTS. AS SUCH, THIS INITIATIVE REPRESENTS AN IMPROVEMENT ACTION, NOT A DIRECT CORRECTIVE ACTION IN RESPONSE TO THESE COMPLAINTS. NEVERTHELESS, WE ACKNOWLEDGE THAT SUCCESSFUL COMPLETION OF THIS PROJECT MAY INDIRECTLY REDUCE THE IDENTIFIED RISK. CLINICAL REVIEW: BASED ON THE VERY LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE PROBLEM APPEARS TO BE MATERIAL INCOMPATIBILITY[?]SPECIFICALLY THE USE OF POLYCARBONATE-BASED COMPONENTS (T-PIECES OF THE AEROGEN® SOLO SYSTEM) WITH VOLATILE ANAESTHETICS LIKE ISOFLURANE IN UNVALIDATED SYSTEM CONFIGURATIONS. ALTHOUGH NO DIRECT PATIENT HARM WAS REPORTED IN THESE INCIDENTS, THE PRESENCE OF CRACKS IN THE AEROGEN® SOLO T-PIECES RAISES IMPORTANT SAFETY CONSIDERATIONS. GIVEN THE STANDARDISED SETUP PROPOSED BY SEDANA MEDICAL IN THEIR IFU, SUCH CRACKS/ FRACTURES OCCURRED IN THE GAS PATHWAY NEAR THE PATIENT'S AIRWAY/FACE. THIS POSES A POTENTIAL RISK OF ASPIRATION OF FOREIGN MATERIAL/FRAGMENTS AND/OR DISRUPTION TO THE VENTILATOR CIRCUIT AND OUTGASSING. CLINICAL SUMMARY: VERY LIMITED INFORMATION HAS BEEN PROVIDED WITH WHICH TO UNDERTAKE THESE ASSESSMENTS. FIVE AEROGEN® T-PIECES HAVE REPORTEDLY FRACTURED/CRACKED, MOST LIKELY DUE TO EXPOSURE TO ISOFLURANE. IT IS WELL DOCUMENTED THAT VOLATILE ANAESTHETIC AGENTS, SUCH AS ISOFLURANE, ARE CORROSIVE TO CERTAIN MATERIALS, INCLUDING POLYCARBONATE. IN THESE CASES, THE ROOT CAUSE APPEARS TO BE MATERIAL INCOMPATIBILITY[?]SPECIFICALLY, THE USE OF POLYCARBONATE-BASED COMPONENTS (I.E. AEROGEN® SOLO T-PIECES) IN SYSTEM CONFIGURATIONS INVOLVING VOLATILE ANAESTHETICS (ISOFLURANE) THAT HAVE NOT BEEN VALIDATED BY THE AEROGEN. IMDRF CODES. F15: RECOGNISED DEVICE OR PROCEDURAL COMPLICATION. MAY BE APPLICABLE: MATERIAL INCOMPATIBILITY BETWEEN VOLATILE ANAESTHETICS AND POLYCARBONATE COMPONENTS IS A KNOWN ISSUE, AS DOCUMENTED IN LITERATURE AND INSTRUCTIONS FOR USE (IFUS). MULTIPLE REPORTS AND MANUFACTURER WARNINGS CITE THE WELL-ESTABLISHED RISK OF STRESS CRACKING OR DEGRADATION. WHEN VOLATILE ANAESTHETICS (ESPECIALLY ISOFLURANE) CONTACT POLYCARBONATE. HENCE, CRACKING OR BREAKING OF COMPONENTS IN THIS CONTEXT IS A RECOGNISED COMPLICATION OF INAPPROPRIATE MATERIAL COMPATIBILITY. F26: NO HEALTH CONSEQUENCES OR IMPACT. IN THIS INSTANCE NO PATIENT HARM OR IMPACT WAS REPORTED. E2403: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS THE INFORMATION AVAILABLE FOR REVIEW STATES NO PATIENT IMPACT.
IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION.
IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATIONIT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATIONIT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATIONIT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATIONIT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1999097 | AEROGEN SOLO ADULT T-PIECE 22MM | AEROGEN SOLO ADULT T-PIECE 22MM | CAF | AEROGEN LTD | AG-AS3010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |