AEROGEN SOLO ADULT T-PIECE 22MM
Report
- Report Number
- 3003399703-2025-22711
- Event Type
- Malfunction
- Date Received
- April 4, 2025
- Date of Event
- February 24, 2025
- Report Date
- June 3, 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
AEROGEN HAVE TAKEN THE APPROPRIATE MEASURES TO REVIEW AND INVESTIGATE THE COMPLAINT RECEIVED. AEROGEN HAVE REQUESTED FURTHER INFORMATION FROM THE REPORTING HEALTHCARE WORKER TO DETERMINE FURTHER DETAILS ON THE EVENT AND HAD REQUESTED THE RETURN OF THE DEVICE. A REVIEW PER AEROGEN'S 'FIELD CORRECTION/REMOVAL PROCEDURE' WAS COMPLETED BASED ON THIS COMPLAINT RECEIVED WHICH MAY POSE A RISK TO PATIENTS. BASED ON THE NATURE OF THE COMPLAINT, AND CURRENT INVESTIGATION IN PROGRESS IT HAS BEEN CONCLUDED THAT NO FIELD CORRECTION OR REMOVAL IS REQUIRED BY AEROGEN AT THIS TIME. THIS WILL BE REVIEWED AS INVESTIGATION PROGRESSES AND IF ANY FURTHER INFORMATION BECOMES AVAILABLE TO AEROGEN WHICH MAY IMPACT THE PREVIOUS NO FSCA DETERMINATION, THE REVIEW AND CONCLUSION WILL BE DOCUMENTED WITHIN THE SUBSEQUENT REPORT.
" 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 (B)(4) 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.
WE HAVE CONDUCTED AN INTIAL INVESTIGATION, CLINICAL REVIEW AND RISK REVIEW - WE ARE PENDING THE FURTHER DETAILS FROM THE CUSTOMER. WE WILL SEND THE FINAL FOLLOW UP ONCE COMPLETE - IN THE NEXT 2 WEEKS.
"THEY HAVE OBSERVED THAT WHEN THEY USE THE AEROGEN WITH THE SEDACONDA IN THIS PATIENT, ABOUT 3 PIECES, WHICH IS THE T TUBE PIECE, HAVE BEEN DAMAGED IN A MATTER OF HOURS." QUESTIONS CAN YOU CONFIRM DURATION OF EXPOSURE AND THE PERCENTAGE OF ANAESTHETIC.? ANSWER : IN RESPONSE TO YOUR QUESTION, THE AEROGEN PART WAS BEING USED AS FOLLOWS: THE DOSE WAS 4 ML/H, AND THE MAXIMUM DOSE IT REACHES IS 1.0%, SINCE THE DEVICE ISN'T CAPABLE OF REACHING 3.5% OF EXHALED GAS. IT'S NOT AN ANESTHESIA MACHINE; IT DEPENDS ON A VENTILATOR, AND IT'S NOT POSSIBLE TO REACH THOSE CONCENTRATIONS. ON THE OTHER HAND, WHAT HAPPENED IS THAT THREE PARTS WERE DAMAGED IN LESS THAN AN HOUR. THEY WERE INSERTED AND IMMEDIATELY BROKE. STATEMENT : PLEASE ACCEPT MY APOLOGIES FOR THE DELAY IN THIS REPORT, I WAS AWAY FROM THE OFFICE AND SEEKING ADVICE AS I HAD CONCERNS THIS MAY LOOK LIKE A DOUBLE REPORT INTERNALLY. AS DESCRIBED IN THE ATTACHED FILE THIS WAS INITIALLY REPORTED AS AN AEROGEN PRO ISSUE, HOWEVER ON INVESTIGATION IT WAS FOUND THE DISTRIBUTOR WAS INFORMED THE PRO WAS DISCONTINUED AND THEREFORE THE CUSTOMER HAD ONLY AEROGEN SOLO AVAILABLE.
"THEY HAVE OBSERVED THAT WHEN THEY USE THE AEROGEN WITH THE SEDACONDA IN THIS PATIENT, ABOUT 3 PIECES, WHICH IS THE T TUBE PIECE, HAVE BEEN DAMAGED IN A MATTER OF HOURS." QUESTIONS CAN YOU CONFIRM DURATION OF EXPOSURE AND THE PERCENTAGE OF ANAESTHETIC.? ANSWER : IN RESPONSE TO YOUR QUESTION, THE AEROGEN PART WAS BEING USED AS FOLLOWS: THE DOSE WAS 4 ML/H, AND THE MAXIMUM DOSE IT REACHES IS 1.0%, SINCE THE DEVICE ISN'T CAPABLE OF REACHING 3.5% OF EXHALED GAS. IT'S NOT AN ANESTHESIA MACHINE; IT DEPENDS ON A VENTILATOR, AND IT'S NOT POSSIBLE TO REACH THOSE CONCENTRATIONS. ON THE OTHER HAND, WHAT HAPPENED IS THAT THREE PARTS WERE DAMAGED IN LESS THAN AN HOUR. THEY WERE INSERTED AND IMMEDIATELY BROKE. STATEMENT : PLEASE ACCEPT MY APOLOGIES FOR THE DELAY IN THIS REPORT, I WAS AWAY FROM THE OFFICE AND SEEKING ADVICE AS I HAD CONCERNS THIS MAY LOOK LIKE A DOUBLE REPORT INTERNALLY. AS DESCRIBED IN THE ATTACHED FILE THIS WAS INITIALLY REPORTED AS AN AEROGEN PRO ISSUE, HOWEVER ON INVESTIGATION IT WAS FOUND THE DISTRIBUTOR WAS INFORMED THE PRO WAS DISCONTINUED AND THEREFORE THE CUSTOMER HAD ONLY AEROGEN SOLO AVAILABLE.
"THEY HAVE OBSERVED THAT WHEN THEY USE THE AEROGEN WITH THE SEDACONDA IN THIS PATIENT, ABOUT 3 PIECES, WHICH IS THE T TUBE PIECE, HAVE BEEN DAMAGED IN A MATTER OF HOURS." QUESTIONS: CAN YOU CONFIRM DURATION OF EXPOSURE AND THE PERCENTAGE OF ANAESTHETIC.? ANSWER: IN RESPONSE TO YOUR QUESTION, THE AEROGEN PART WAS BEING USED AS FOLLOWS: THE DOSE WAS 4 ML/H, AND THE MAXIMUM DOSE IT REACHES IS 1.0%, SINCE THE DEVICE ISN'T CAPABLE OF REACHING 3.5% OF EXHALED GAS. IT'S NOT AN ANESTHESIA MACHINE; IT DEPENDS ON A VENTILATOR, AND IT'S NOT POSSIBLE TO REACH THOSE CONCENTRATIONS. ON THE OTHER HAND, WHAT HAPPENED IS THAT THREE PARTS WERE DAMAGED IN LESS THAN AN HOUR. THEY WERE INSERTED AND IMMEDIATELY BROKE. STATEMENT: PLEASE ACCEPT MY APOLOGIES FOR THE DELAY IN THIS REPORT, I WAS AWAY FROM THE OFFICE AND SEEKING ADVICE AS I HAD CONCERNS THIS MAY LOOK LIKE A DOUBLE REPORT INTERNALLY. AS DESCRIBED IN THE ATTACHED FILE THIS WAS INITIALLY REPORTED AS AN AEROGEN PRO ISSUE, HOWEVER ON INVESTIGATION IT WAS FOUND THE DISTRIBUTOR WAS INFORMED THE PRO WAS DISCONTINUED AND THEREFORE THE CUSTOMER HAD ONLY AEROGEN SOLO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2324350 | AEROGEN SOLO ADULT T-PIECE 22MM | AEROGEN SOLO T-PIECE | CAF | AEROGEN LTD | AG-AS3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |