BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROGEN SOLO T-PIECE

    MDR report key: 22008648 · Received May 13, 2025

    Report

    Report Number
    3003399703-2025-22754
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 21, 2025
    Report Date
    June 3, 2025
    Manufacturer
    AEROGEN LTD
    Product Code
    CAF
    PMA / PMN Number
    K070642
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    " 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.

    Additional Manufacturer Narrative · 0

    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 ANYFURTHER INFORMATION BECOMES AVAILABLE TO AEROGEN WHICH MAY IMPACT THE PREVIOUS NO FSCA DETERMINATION, THE REVIEW AND CONCLUSION WILL BE DOCUMENTED WITHIN THE SUBSEQUENT REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 22 MM T-PIECE SUSTAINED IMMEDIATE STRUCTURAL DAMAGE UPON EXPOSURE TO ISOFLURANE, A VOLATILE ANESTHETIC AGENT, DURING MECHANICAL VENTILATION.

    Description of Event or Problem · 0

    IT 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
    2414303 AEROGEN SOLO T-PIECE AEROGEN SOLO T-PIECE CAF AEROGEN LTD AG-AS3010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown