AEROGEN SOLO
Report
- Report Number
- 3003399703-2025-22828
- Event Type
- Death
- Date Received
- July 8, 2025
- Date of Event
- November 16, 2024
- Report Date
- August 13, 2025
- Manufacturer
- AEROGEN LTD
- Product Code
- CAF
- PMA / PMN Number
- K070642
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
" ON NOVEMBER 16, 2024, AN ADVERSE EVENT OCCURRED DURING A TRANSPLANT INVOLVING THE USE OF A PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WITH AN AEROGEN SOLO NEBULISER. THE PATIENT, A 57-YEAR OLD MALE, EXPERIENCED PROLONGED RESPIRATORY CHALLENGES DUE TO AN INCORRECT SETUP OF THE CIRCUIT, WHICH LIKELY CAUSED THE FILTER TO CLOG. THE FILTER AEROGEN SOLO NEBULISER WAS INTENDED TO DELIVER INHALED EPOPROSTENOL AFTER THE PATIENT WAS LIBERATED FROM CARDIOPULMONARY BYPASS. THE PATIENT WAS TAKEN OFF BYPASSAND CONNECTED TO A VENTILATOR FOR THE DELIVERY OF INHALED APOPROSTENOL. HOWEVER, WITHIN 2 HOURS, THE PATIENT'S TIDAL VOLUMES DECREASED, INDICATING DIFFICULTY IN VENTILATION AND OXYGENATION, LIKELY DUE TO THE CLOGGED FILTER OBSTRUCTING AIRFLOW AND EPOPROSTENOL DELIVERY FROM THE AEROGEN SOLO NEBULIZER. THIS LED TO AN ANOXIC BRAIN INJURY AND ULITMATELY THE PATIENTS DEATH, WHICH OCCURED ON (B)(6) 2024. THE ADVERSE EVENT WAS IDENTIFIED AS POTENTIALLY LINKED TO THE SETUP OF THE FILTER WITH THE AEROGEN SOLO NEBULIZER AFTER DISCOVERING THAT THE FILTER ON THE VENTILATOR HAD CLOGGED, WHICH OBSTRUCTED THE DELIVERY OF OXYGEN AND EPOPROSTENOL." 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. CLINICAL CONCLUSION BASED ON THE INFORMATION AVAILABLE THE DEATH REPORTED WAS LIKELY ATTRIBUTABLE SOLELY TO USER ERROR. THIS EVENT DID NOT OCCUR, AS CONFIRMED BY THE USER FACILITY, AS A RESULT OF DEVICE [21 CFR 803.3]: - FAILURE; - MALFUNCTION; - IMPROPER OR INADEQUATE DESIGN; - MANUFACTURE; OR - LABELLING. THE USER FACILITY REPRESENTATIVE CONFIRMED THAT "USER ERROR", IN THIS INSTANCE A MISTAKE MADE BY AN ATTENDING HEALTH CARE PROFESSIONAL IN THE CONFIGURATION IN WHICH THE PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WAS PLACED IN RELATION TO THE AEROGEN® SOLO NEBULISER WAS THE CAUSE OF THIS EVENT12. THERE WAS NO PERFORMANCE ISSUE RELATED TO THE AEROGEN® SOLO NEBULISER REPORTED BY THE USER FACILITY. SUMMARY NO PERFORMANCE ISSUE WAS REPORTED WITH THE AEROGEN MEDICAL DEVICE INVOLVED. THE USER FACILITY CONFIRMED THAT AN "INCORRECT" CONFIGURATION OF THE MEDICAL DEVICES BY AN ATTENDING CLINICAL STAFF MEMBER WAS THE CAUSE OF THE EVENT. BASED ON THE INFORMATION AVAILABLE THE FOLLOWING IMDRF ANNEX A, E & F CODES MAY BE CONSIDERED. APPROPRIATE: A24 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. E0726 - HYPOXIA. F22 - UNEXPECTED DETERIORATION. F23 - UNEXPECTED MEDICAL INTERVENTION. F02 - DEATH. THE FOLLOWING QUESTIONS (BOLD ITALICS) WERE PROVIDED TO THE USER FACILITY BY AEROGEN LTD. ON THE XXX. A WRITTEN RESPONSE (NORMAL TEXT) WAS PROVIDED TO QUESTION 1 ONLY. VERBAL RESPONSES (REPRODUCED AS FAITHFULLY AS POSSIBLE - NORMAL TEXT) WERE PROVIDED TO OTHER QUESTIONS IN THE FACE-TO-FACE INTERVIEW BY (B)(6) REPRESENTATIVES L PACKER ON THE 27TH JUNE 2025. DUE TO ONGOING LITIGATION (B)(6) DECLINE TO RESPOND TO SOME QUESTIONS ASKED. THESE ARE MARKED [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] BELOW. 1. COULD YOU DESCRIBE THE FORM OF RESPIRATORY SUPPORT (OR MECHANICAL VENTILATION) THE PATIENT WAS RECEIVING AT THE TIME, INCLUDING CONFIGURATION (ACTIVE OR PASSIVE HUMIDIFICATION, HUMIDIFIER USED, DUAL/SINGLE LIMB ETC.) AND INTERFACE TO THE PATIENT (E.G., ETT VS. TRACHEOSTOMY TUBE). MECHANICAL VENTILATION WAS ACHIEVED USING AN GE DATEX-OHMEDA AISYS CS2 ANESTHESIA SYSTEM, CONNECTED VIA A SINGLE LIMB ANESTHESIA CIRCUIT TO THE ETT OF THE PATIENT. THE PATIENT-SIDE HME FILTER WAS REMOVED FROM THE CIRCUIT. THERE WERE VENTILATOR-SIDE PLEATED HYDROPHOBIC MEMBRANE FILTERS (PALL ULTIPOR 55) PLACED BOTH IN THE INSPIRATORY AND EXPIRATORY PORT. THE AEROGEN SOLO NEBULIZER WAS PLACED IN THE INSPIRATORY PORT. THE INCORRECT SETUP WAS SUCH THAT THE AEROGEN SOLO NEBULIZER WAS PLACED IN THE INSPIRATORY PORT OF THE VENTILATOR FIRST, FOLLOWED BY THE PALL ULTIPOR FILTER, FOLLOWED BY THE ANESTHESIA CIRCUIT, LIKELY CAUSING THE HYDROPHOBIC FILTER TO CLOG WITH AERSOSOLIZED EPOPROSTANOL. 2. WAS THE PALL ULTIPOR 55 FILTER BEING EMPLOYED AS A FILTER (ON THE MACHINE SIDE PROTECTING THE EXPIRATORY PORT) OR AS A HME (AND POSITIONED PROXIMAL TO THE PATIENT)? A. IF THE PALL ULTIPOR 55 FILTER WAS PLACED ON THE EXPIRATORY LIMB, WAS ANOTHER HME EMPLOYED OR WAS ACTIVE HUMIDIFICATION USED? PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WAS PLACED AT BOTH THE INSPIRATORY AND EXPIRATORY POT OF THE VENTILATOR. THIS IS NORMAL PRACTICE AT THIS INSTITUTION. 3. COULD YOU DESCRIBE WHERE THE AEROGEN® SOLO NEBULISER WAS PLACED IN THIS CIRCUIT IN RELATION TO THE PALL ULTIPOR 55 FILTER? N/A - CONSIDERED ADDRESSED IN PREVIOUS ANSWERS TO Q1 & Q2. 4. WAS THE PALL ULTIPOR 55 FILTER PLACED [?]UPSTREAM' OF THE AEROGEN® SOLO NEBULISER, I.E., PROXIMAL TO THE PATIENT WITH RESPECT TO THE POSITION OF NEBULISER POSITION? OR WAS THE AEROGEN® SOLO NEBULISER BETWEEN THE PALL ULTIPOR 55 FILTER AND THE PATIENT? YES. THE FILTER WAS PLACED BETWEEN THE NEBULISER AND THE PATIENT. 5. WHAT WAS THE INDICATION FOR AEROSOL DRUG DELIVERY USING THE AEROGEN® SOLO NEBULISER? REDUCTION OF PULMONARY VASCULAR RESISTANCE (PVR), RELIEF OF RIGHT VENTRICULAR AFTERLOAD. INSTITUTIONAL PRACTICE FOR PREVENTION OF PRIMARY GRAFT DYSFUNCTION (REFERENCED TO RCT CONDUCED AT (B)(6) IN 2022 - SEE BIBLIOGRAPHY). 6. WHEN WAS THE AEROGEN SOLO FIRST USED FOLLOWING THE PATIENT'S SEPARATION FROM BYPASS? 2 HOURS. 7. HOW LONG WAS THE NEBULISER IN USE DURING THE POST-OPERATIVE PERIOD? [CONSIDERED ADDRESSED BY RESPONSE TO Q6] 8. WERE THE STAFF INVOLVED FAMILIAR WITH AEROGEN'S IFU AND THE CORRECT SETUP OF THE DEVICE? YES, (B)(6) STAFF ARE VERY FAMILIAR WITH AEROGEN DEVICES, THE IFU AND USE AEROGEN NEBULISERS FOR IEPO AS STANDARD PRACTICE. 9. HAS THIS TYPE OF CONFIGURATION (AEROGEN SOLO WITH IN-LINE FILTER) BEEN USED BEFORE AT YOUR FACILITY, AND IF SO, HAVE ANY SIMILAR ISSUES OCCURRED? THIS SPECIFIC CONFIGURATION, AS OCCURRED IN THIS INCIDENT - NO. THE CORRECT CONFIGURATION, WITH A FILTER ON THE INSPIRATORY PORT & EXPIRATORY PORT, WITH AN AEROGEN NEBULISER PROXIMAL TO THE PATIENT IS STANDARD IN (B)(6). PAGE 11 OF 16 RELATED TO THE FILTER OBSTRUCTION: 10. IN THIS SPECIFIC CASE HOW LONG WAS THE PALL ULTIPOR 55 FILTER USED? AND A. AT WHAT FREQUENCY ARE THESE FILTERS TYPICALLY CHECKED ACCORDING TO YOUR INTERNAL SOPS, AND CHANGED/REPLACED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 11. SPECIFICALLY, WAS THE FILTER SATURATED OR [?]CLOGGED'/'OBSTRUCTED' WITH PARTICULATE LIKE CRYSTALS? YES. THE FILTER WAS NOTED TO BE SATURATED BY THE HCPS. NO - THERE WAS NO PARTICULATE VISIBLE. 12. WAS THERE VISIBLE CONDENSATION OR SATURATION NOTED IN THE FILTER OR CIRCUIT? NO, THE SATURATION WAS [?]NON-OBVIOUS' TO THE ATTENDING CLINICAL TEAM. 13. AT WHAT POINT WAS A CLOGGED OR OBSTRUCTED FILTER SUSPECTED OR CONFIRMED? THE PROFOUND DROP IN TIDAL VOLUME WAS THE FIRST INDICATION TO THE CLINICAL STAFF OF A POTENTIAL ISSUE. IT WAS DISCOVERED SHORTLY AFTER THIS. 14. AT WHAT POINT WAS A CLOGGED OR OBSTRUCTED FILTER SUSPECTED OR CONFIRMED? CONSIDERED ADDRESSED BY RESPONSE TO Q13. RELATED TO THE AE: 15. WAS A PRE-USE CHECK OR INSPECTION OF THE BREATHING CIRCUIT AND FILTER CONDUCTED PRIOR TO INITIATION? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 16. WAS A PRE-USE CHECK OF THE VENTILATOR PERFORMED TO ENSURE THE PATIENT SETTINGS, ALARMS AND MONITORING DEVICES ARE ACCURATELY CONNECTED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 17. THE REPORT REFERS TO A PROLONGED RESPIRATORY CHALLENGE[?]COULD YOU PROVIDE MORE DETAIL AROUND THIS? HOW LONG DID IT PERSIST AND WHAT SYMPTOMS WERE NOTICED/OBSERVED? AFTER THE DROP IN TIDAL VOLUME THE [?]RESPIRATORY CHALLENGE' OCCURRED FOR BETWEEN 15-20 MINS UNTIL THE SATURATED FILTER WAS DISCOVERED. WHEN THIS WAS REPLACED, AND CONFIGURATION CORRECT, THE PATIENT WAS VENTILATED SUCCESSFULLY. 18. WHAT WERE THE PATIENT'S OXYGENATION LEVELS (SPO2 OR SIMILAR) BEFORE THE AE. [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 19. RELATED TO THE "DECREASED TIDAL VOLUMES" AND "DIFFICULTY IN VENTILATION" WERE ANY OF THE FOLLOWING ALARMS RECORDED: A. HIGH PEEP, OR B. HIGH AIRWAY PRESSURE ALARM, OR C. LOW EXHALED TIDAL VOLUME ALARM, OR D. APNEA OR LOW MINUTE VENTILATION, OR E. FLOW SENSOR OR EXPIRATORY VALVE ERROR. NO - NO ALARMS SOUNDED TO ALERT THE CLINICAL TEAM. THE FIRST INDICATION OF AN ISSUE WAS THE DROP IN TIDAL VOLUME. 20. WERE KEY RESPIRATORY PARAMETERS SUCH AS TIDAL VOLUME, PEAK PRESSURES, RESISTANCE, OR ETCO CONTINUOUSLY MONITORED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 21. WHAT CLINICAL MONITORING WAS IN PLACE (E.G., SPO[?], ETCO[?], FIO[?] TRENDS) [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 22. WHAT INTERVENTIONS WERE MADE IN RESPONSE TO THE OBSERVED DETERIORATION IN VENTILATION AND OXYGENATION? PAGE 12 OF 16 A BRONCHOSCOPY WAS ATTEMPTED TO DETERMINE IF AIRWAY OBSTRUCTION WAS PRESENT. UPON DETECTION THE FILTER WAS REMOVED - AT WHICH POINT THE PATIENT COULD BE VENTILATED SUCCESSFULLY. 23. WHEN WAS THE ONSET OF ANOXIC BRAIN INJURY FIRST SUSPECTED OR CONFIRMED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 24. WERE OTHER POSSIBLE CAUSES OF HYPOXIA (E.G., AIRWAY OBSTRUCTION, PULMONARY EMBOLISM, BRONCHOSPASM) CONSIDERED OR RULED OUT? CONSIDERED ADDRESSED BY RESPONSE TO Q22 25. THE AE REPORT STATES THE AE WAS "LIKELY DUE TO A CLOGGED FILTER OBSTRUCTING AIRFLOW" AND REFERS TO A 2 HOUR TIME PERIOD OF WHICH PERIOD "DECREASED TIDAL VOLUME, DIFFICULTY IN VENTILATION AND OXYGENATION OCCURRED". WAS THE "CLOGGED" FILTER NOTED DURING THIS PERIOD OR AFTER? CONSIDERED ADDRESSED BY PREVIOUS ANSWERS. FINALLY: 26. HAS ANY CHANGE BEEN MADE TO LOCAL PRACTICE OR PROTOCOLS AS A RESULT OF THIS EVENT? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] 27. IS THE AEROGEN DEVICE AVAILABLE TO BE SENT BACK FOR INVESTIGATION. NO - THE AEROGEN DEVICE WAS NOT RETAINED. CLINICAL STAFF REPORTED NO ISSUE WITH THE AEROGEN DEVICE, AND IT WAS NOT RETAINED. THE PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WAS RETAINED.
COMMENTS FROM CALL WITH (B)(6): THEY STATED CLEARLY THAT THEIR STAFF PLACED THE AEROGEN DEVICE IN THE IMV CIRCUIT INCORRECTLY - WITH THE AEROGEN DEVICE DISTAL TO A FILTER (I.E., THE PATHWAY FOR THE AEROSOL TO THE PATIENT WAS OBSTRUCTED BY THE FILTER). THIS THEY STATED THIS WAS DUE TO AN ERROR BY A MEMBER OF THEIR STAFF. THE AEROGEN DEVICE WAS NOT RETAINED AS THEY FOUND NO FAULT WITH IT AND THEY DO NOT ATTRIBUTE THE ADVERSE EVENT TO THE AEROGEN DEVICE. FROM THEIR PERSPECTIVE THE USE OF THE AEROGEN DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. QUESTIONS: A WRITTEN RESPONSE (NORMAL TEXT) WAS PROVIDED TO QUESTION 1 ONLY. VERBAL RESPONSES (REPRODUCED AS FAITHFULLY AS POSSIBLE - NORMAL TEXT) WERE PROVIDED TO OTHER QUESTIONS IN THE FACE-TO-FACE INTERVIEW BY (B)(6) REPRESENTATIVES L PACKER ON THE (B)(6) 2025. DUE TO ONGOING LITIGATION (B)(6) DECLINE TO RESPOND TO SOME QUESTIONS ASKED. THESE ARE MARKED [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] BELOW. COULD YOU DESCRIBE THE FORM OF RESPIRATORY SUPPORT (OR MECHANICAL VENTILATION) THE PATIENT WAS RECEIVING AT THE TIME, INCLUDING CONFIGURATION (ACTIVE OR PASSIVE HUMIDIFICATION, HUMIDIFIER USED, DUAL/SINGLE LIMB ETC.) AND INTERFACE TO THE PATIENT (E.G., ETT VS. TRACHEOSTOMY TUBE). MECHANICAL VENTILATION WAS ACHIEVED USING AN GE DATEX-OHMEDA AISYS CS2 ANESTHESIA SYSTEM, CONNECTED VIA A SINGLE LIMB ANESTHESIA CIRCUIT TO THE ETT OF THE PATIENT. THE PATIENT-SIDE HME FILTER WAS REMOVED FROM THE CIRCUIT. THERE WERE VENTILATOR-SIDE PLEATED HYDROPHOBIC MEMBRANE FILTERS (PALL ULTIPOR 55) PLACED BOTH IN THE INSPIRATORY AND EXPIRATORY PORT. THE AEROGEN SOLO NEBULIZER WAS PLACED IN THE INSPIRATORY PORT. THE INCORRECT SETUP WAS SUCH THAT THE AEROGEN SOLO NEBULIZER WAS PLACED IN THE INSPIRATORY PORT OF THE VENTILATOR FIRST, FOLLOWED BY THE PALL ULTIPOR FILTER, FOLLOWED BY THE ANESTHESIA CIRCUIT, LIKELY CAUSING THE HYDROPHOBIC FILTER TO CLOG WITH AERSOSOLIZED EPOPROSTANOL. WAS THE PALL ULTIPOR 55 FILTER BEING EMPLOYED AS A FILTER (ON THE MACHINE SIDE PROTECTING THE EXPIRATORY PORT) OR AS A HME (AND POSITIONED PROXIMAL TO THE PATIENT)? A. IF THE PALL ULTIPOR 55 FILTER WAS PLACED ON THE EXPIRATORY LIMB, WAS ANOTHER HME EMPLOYED OR WAS ACTIVE HUMIDIFICATION USED? PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WAS PLACED AT BOTH THE INSPIRATORY AND EXPIRATORY POT OF THE VENTILATOR. THIS IS NORMAL PRACTICE AT THIS INSTITUTION. COULD YOU DESCRIBE WHERE THE AEROGEN® SOLO NEBULISER WAS PLACED IN THIS CIRCUIT IN RELATION TO THE PALL ULTIPOR 55 FILTER? N/A - CONSIDERED ADDRESSED IN PREVIOUS ANSWERS TO Q1 & Q2. WAS THE PALL ULTIPOR 55 FILTER PLACED UPSTREAM' OF THE AEROGEN® SOLO NEBULISER, I.E., PROXIMAL TO THE PATIENT WITH RESPECT TO THE POSITION OF NEBULISER POSITION? OR WAS THE AEROGEN® SOLO NEBULISER BETWEEN THE PALL ULTIPOR 55 FILTER AND THE PATIENT? YES. THE FILTER WAS PLACED BETWEEN THE NEBULISER AND THE PATIENT. WHAT WAS THE INDICATION FOR AEROSOL DRUG DELIVERY USING THE AEROGEN® SOLO NEBULISER? REDUCTION OF PULMONARY VASCULAR RESISTANCE (PVR), RELIEF OF RIGHT VENTRICULAR AFTERLOAD. INSTITUTIONAL PRACTICE FOR PREVENTION OF PRIMARY GRAFT DYSFUNCTION (REFERENCED TO RCT CONDUCED AT (B)(6) IN 2022 - SEE BIBLIOGRAPHY). WHEN WAS THE AEROGEN SOLO FIRST USED FOLLOWING THE PATIENT'S SEPARATION FROM BYPASS? 2 HOURS. HOW LONG WAS THE NEBULISER IN USE DURING THE POST-OPERATIVE PERIOD? [CONSIDERED ADDRESSED BY RESPONSE TO Q6] WERE THE STAFF INVOLVED FAMILIAR WITH AEROGEN'S IFU AND THE CORRECT SETUP OF THE DEVICE? YES, (B)(6) STAFF ARE VERY FAMILIAR WITH AEROGEN DEVICES, THE IFU AND USE AEROGEN NEBULISERS FOR IEPO AS STANDARD PRACTICE. HAS THIS TYPE OF CONFIGURATION (AEROGEN SOLO WITH IN-LINE FILTER) BEEN USED BEFORE AT YOUR FACILITY, AND IF SO, HAVE ANY SIMILAR ISSUES OCCURRED? THIS SPECIFIC CONFIGURATION, AS OCCURRED IN THIS INCIDENT - NO. THE CORRECT CONFIGURATION, WITH A FILTER ON THE INSPIRATORY PORT & EXPIRATORY PORT, WITH AN AEROGEN NEBULISER PROXIMAL TO THE PATIENT IS STANDARD IN (B)(6). RELATED TO THE FILTER OBSTRUCTION: IN THIS SPECIFIC CASE HOW LONG WAS THE PALL ULTIPOR 55 FILTER USED? AND A. AT WHAT FREQUENCY ARE THESE FILTERS TYPICALLY CHECKED ACCORDING TO YOUR INTERNAL SOPS, AND CHANGED/REPLACED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] SPECIFICALLY, WAS THE FILTER SATURATED OR CLOGGED'/'OBSTRUCTED' WITH PARTICULATE LIKE CRYSTALS? YES. THE FILTER WAS NOTED TO BE SATURATED BY THE HCPS. NO - THERE WAS NO PARTICULATE VISIBLE. WAS THERE VISIBLE CONDENSATION OR SATURATION NOTED IN THE FILTER OR CIRCUIT? NO, THE SATURATION WAS NON-OBVIOUS' TO THE ATTENDING CLINICAL TEAM. AT WHAT POINT WAS A CLOGGED OR OBSTRUCTED FILTER SUSPECTED OR CONFIRMED? THE PROFOUND DROP IN TIDAL VOLUME WAS THE FIRST INDICATION TO THE CLINICAL STAFF OF A POTENTIAL ISSUE. IT WAS DISCOVERED SHORTLY AFTER THIS. AT WHAT POINT WAS A CLOGGED OR OBSTRUCTED FILTER SUSPECTED OR CONFIRMED? CONSIDERED ADDRESSED BY RESPONSE TO Q13. RELATED TO THE AE: WAS A PRE-USE CHECK OR INSPECTION OF THE BREATHING CIRCUIT AND FILTER CONDUCTED PRIOR TO INITIATION? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] WAS A PRE-USE CHECK OF THE VENTILATOR PERFORMED TO ENSURE THE PATIENT SETTINGS, ALARMS AND MONITORING DEVICES ARE ACCURATELY CONNECTED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] THE REPORT REFERS TO A PROLONGED RESPIRATORY CHALLENGE COULD YOU PROVIDE MORE DETAIL AROUND THIS? HOW LONG DID IT PERSIST AND WHAT SYMPTOMS WERE NOTICED/OBSERVED? AFTER THE DROP IN TIDAL VOLUME THE RESPIRATORY CHALLENGE OCCURRED FOR BETWEEN 15-20 MINS UNTIL THE SATURATED FILTER WAS DISCOVERED. WHEN THIS WAS REPLACED, AND CONFIGURATION CORRECT, THE PATIENT WAS VENTILATED SUCCESSFULLY. WHAT WERE THE PATIENT'S OXYGENATION LEVELS (SPO2 OR SIMILAR) BEFORE THE AE. [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] RELATED TO THE "DECREASED TIDAL VOLUMES" AND "DIFFICULTY IN VENTILATION" WERE ANY OF THE FOLLOWING ALARMS RECORDED: A. HIGH PEEP, OR B. HIGH AIRWAY PRESSURE ALARM, OR C. LOW EXHALED TIDAL VOLUME ALARM, OR D. APNEA OR LOW MINUTE VENTILATION, OR E. FLOW SENSOR OR EXPIRATORY VALVE ERROR. NO - NO ALARMS SOUNDED TO ALERT THE CLINICAL TEAM. THE FIRST INDICATION OF AN ISSUE WAS THE DROP IN TIDAL VOLUME. WERE KEY RESPIRATORY PARAMETERS SUCH AS TIDAL VOLUME, PEAK PRESSURES, RESISTANCE, OR ETCO CONTINUOUSLY MONITORED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] WHAT CLINICAL MONITORING WAS IN PLACE (E.G., SPO, ETCO, FIO TRENDS)? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] WHAT INTERVENTIONS WERE MADE IN RESPONSE TO THE OBSERVED DETERIORATION IN VENTILATION AND OXYGENATION? A BRONCHOSCOPY WAS ATTEMPTED TO DETERMINE IF AIRWAY OBSTRUCTION WAS PRESENT. UPON DETECTION THE FILTER WAS REMOVED - AT WHICH POINT THE PATIENT COULD BE VENTILATED SUCCESSFULLY. WHEN WAS THE ONSET OF ANOXIC BRAIN INJURY FIRST SUSPECTED OR CONFIRMED? [DECLINED TO ANSWER - NO RESPONSE AVAILABLE] WERE OTHER POSSIBLE CAUSES OF HYPOXIA (E.G., AIRWAY OBSTRUCTION, PULMONARY EMBOLISM, BRONCHOSPASM) CONSIDERED OR RULED OUT? CONSIDERED ADDRESSED BY RESPONSE TO Q22 THE AE REPORT STATES THE AE WAS "LIKELY DUE TO A CLOGGED FILTER OBSTRUCTING AIRFLOW" AND REFERS TO A 2 HOUR TIME PERIOD OF WHICH PERIOD "DECREASED TIDAL VOLUME, DIFFICULTY IN VENTILATION AND OXYGENATION OCCURRED". WAS THE "CLOGGED" FILTER NOTED DURING THIS PERIOD OR AFTER? CONSIDERED ADDRESSED BY PREVIOUS ANSWERS.
ON NOVEMBER 16, 2024, AN ADVERSE EVENT OCCURRED DURING A TRANSPLANT INVOLVING THE USE OF A PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WITH AN AEROGEN SOLO NEBULISER. THE PATIENT, A 57-YEAR OLD MALE, EXPERIENCED PROLONGED RESPIRATORY CHALLENGES DUE TO AN INCORRECT SETUP OF THE CIRCUIT, WHICH LIKELY CAUSED THE FILTER TO CLOG. THE FILTER AEROGEN SOLO NEBULISER WAS INTENDED TO DELIVER INHALED EPOPROSTENOL AFTER THE PATIENT WAS LIBERATED FROM CARDIOPULMONARY BYPASS. THE PATIENT WAS TAKEN OFF BYPASS AND CONNECTED TO A VENTILATOR FOR THE DELIVERY OF INHALED APOPROSTENOL. HOWEVER, WITHIN 2 HOURS, THE PATIENT'S TIDAL VOLUMES DECREASED, INDICATING DIFFICULTY IN VENTILATION AND OXYGENATION, LIKELY DUE TO THE CLOGGED FILTER OBSTRUCTING AIRFLOW AND EPOPROSTENOL DELIVERY FROM THE AEROGEN SOLO NEBULIZER. THIS LED TO AN ANOXIC BRAIN INJURY AND ULITMATELY THE PATIENTS DEATH, WHICH OCCURED ON (B)(6) 2024. THE ADVERSE EVENT WAS IDENTIFIED AS POTENTIALLY LINKED TO THE SETUP OF THE FILTER WITH THE AEROGEN SOLO NEBULIZER AFTER DISCOVERING THAT THE FILTER ON THE VENTILATOR HAD CLOGGED, WHICH OBSTRUCTED THE DELIVERY OF OXYGEN AND EPOPROSTENOL.
ON (B)(6) 2024, AN ADVERSE EVENT OCCURRED DURING A TRANSPLANT INVOLVING THE USE OF A PALL ULTIPOR 55 BREATHING CIRCUIT FILTER WITH AN AEROGEN SOLO NEBULISER. THE PATIENT, A 57-YEAR-OLD MALE, EXPERIENCED PROLONGED RESPIRATORY CHALLENGES DUE TO AN INCORRECT SETUP OF THE CIRCUIT, WHICH LIKELY CAUSED THE FILTER TO CLOG. THE FILTER AEROGEN SOLO NEBULISER WAS INTENDED TO DELIVER INHALED EPOPROSTENOL AFTER THE PATIENT WAS LIBERATED FROM CARDIOPULMONARY BYPASS. THE PATIENT WAS TAKEN OFF BYPASSAND CONNECTED TO A VENTILATOR FOR THE DELIVERY OF INHALED APOPROSTENOL. HOWEVER, WITHIN 2 HOURS, THE PATIENT'S TIDAL VOLUMES DECREASED, INDICATING DIFFICULTY IN VENTILATION AND OXYGENATION, LIKELY DUE TO THE CLOGGED FILTER OBSTRUCTING AIRFLOW AND EPOPROSTENOL DELIVERY FROM THE AEROGEN SOLO NEBULIZER. THIS LED TO AN ANOXIC BRAIN INJURY AND ULITMATELY THE PATIENT'S DEATH, WHICH OCCURED ON (B)(6) 2024. THE ADVERSE EVENT WAS IDENTIFIED AS POTENTIALLY LINKED TO THE SETUP OF THE FILTER WITH THE AEROGEN SOLO NEBULIZER AFTER DISCOVERING THAT THE FILTER ON THE VENTILATOR HAD CLOGGED, WHICH OBSTRUCTED THE DELIVERY OF OXYGEN AND EPOPROSTENOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340438 | AEROGEN SOLO | AEROGEN SOLO | CAF | AEROGEN LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death | PALL ULTIPOR 55)| PALL ULTIPOR 55) |