BREELIB INHALATION SYSTEM
Report
- Report Number
- 3008702754-2024-07123
- Event Type
- Injury
- Date Received
- December 17, 2024
- Date of Event
- November 13, 2024
- Report Date
- May 29, 2025
- Manufacturer
- VECTURA GROUP LTD.
- Product Code
- CAF
- PMA / PMN Number
- K142059
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BREELIB¿ IS NOT DESIGNED FOR EMERGENCY AND LIFE SUPPORT USE. THE BREELIB RISK MANAGEMENT FILE CONSIDERS THAT CHRONIC MISSED DOSES CAN RESULT IN INJURY OR IMPAIRMENT WHICH MAY REQUIRE PROFESSIONAL MEDICAL INTERVENTION. VENTAVIS® IS ADMINISTERED USING THE BREELIB BETWEEN 6- 9 TIMES PER DAY DEPENDING UPON INDIVIDUAL PATIENT NEED AND TOLERABILITY TO VENTAVIS®. VENTAVIS® IS NOT FIRST LINE THERAPY FOR PAH, WHICH IS A PROGRESSIVE, INCURABLE DISEASE THAT WILL EVENTUALLY LEAD TO RIGHT HEART FAILURE AND DEATH. VENTAVIS® IMPROVES THE CLINICAL COURSE OF PAH BUT CAN ONLY DELAY DISEASE PROGRESSION. VENTAVIS® IS GENERALLY PRESCRIBED AS PART OF A TRIPLE THERAPY FOR PAH, ALTHOUGH NO DETAILS OF CONCOMITANT MEDICATION HAVE BEEN PROVIDED FOR THIS CASE. BREELIB INHALATION SYSTEM IS NOT 510K CLEARED. THE REPORT IS BEING SUBMITTED TO THE US FDA AS THE BREELIB DEVICE IS A SIMILAR DEVICE TO THE 510K CLEARED FOX MOBILE DEVICE.
BREELIB IS NOT 510(K) CLEARED/ THIS REPORT IS BEING SUBMITTED AS BREELIB IS CONSIDERED A 'SIMILAR' DEVICE TO 510(K) CLEARED FOX MOBILE DEVICE. BREELIB¿ IS NOT DESIGNED FOR EMERGENCY AND LIFE SUPPORT USE. THE BREELIB RISK MANAGEMENT FILE CONSIDERS THAT CHRONIC MISSED DOSES CAN RESULT IN INJURY OR IMPAIRMENT WHICH MAY REQUIRE PROFESSIONAL MEDICAL INTERVENTION. PATIENTS ARE SUPPLIED WITH RESERVE DEVICES AND SPARE CONSUMABLES TO ENABLE THERAPY TO CONTINUE IN THE EVENT OF ANY DEVICE ISSUES. VENTAVIS® IS ADMINISTERED USING THE BREELIB BETWEEN 6- 9 TIMES PER DAY DEPENDING UPON INDIVIDUAL PATIENT NEED AND TOLERABILITY TO VENTAVIS®. VENTAVIS® IS NOT FIRST LINE THERAPY FOR PAH, WHICH IS A PROGRESSIVE, INCURABLE DISEASE THAT WILL EVENTUALLY LEAD TO RIGHT HEART FAILURE AND DEATH. VENTAVIS® IMPROVES THE CLINICAL COURSE OF PAH BUT CAN ONLY DELAY DISEASE PROGRESSION. VENTAVIS® IS GENERALLY PRESCRIBED AS PART OF A TRIPLE THERAPY FOR PAH, ALTHOUGH NO DETAILS OF CONCOMITANT MEDICATION HAVE BEEN PROVIDED FOR THIS CASE.
THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR (B)(4), WITH REF NO. (B)(4) AND VECTURA REFERENCE (B)(4) ON (B)(6) 2024 CONCERNING THE BREELIB INHALATION SYSTEM. (B)(4) AND VECTURA HAVE A CO-PARTNER RELATIONSHIP WHERE THE BREELIB MEDICAL DEVICE (MANUFACTURED BY VECTURA) IS SUPPLIED BY (B)(4) TO PATIENTS TO USE WITH VENTAVIS (ILOPROST) THERAPY FOR PULMONARY ARTERIAL HYPERTENSION (PAH) MANAGEMENT IN THE EU AND LATIN AMERICAN MARKETS. BREELIB INHALATION SYSTEM IS NOT 510K CLEARED. THE REPORT IS BEING SUBMITTED TO THE US FDA AS THE BREELIB DEVICE IS A SIMILAR DEVICE TO THE 510K CLEARED FOX MOBILE DEVICE. THE CASE CONCERNS AN INCIDENT THAT OCCURRED IN COLOMBIA WITH A 60-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED THROUGH THE COMPLAINT FORM RELATING TO THE EVENT RECEIVED ON 19-NOV-2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS 20MCG/ML (RESPIRATORY) 6 DF AT AN UNSPECIFIED FREQUENCY, IN (B)(6) 2007. THE START DATE OF USING THE BREELIB DEVICE INVOLVED IN THIS EVENT TO ADMINISTER THE DRUG WAS GIVEN AS (B)(6) 2024 (EXACT DATE UNKNOWN). THE PATIENT STARTED USING THE BREELIB DEVICE FOR PERFORMING ILOPROST NEBULISATIONS BETWEEN (B)(6) 2023 (EXACT DATE UNKNOWN). IT WAS NOTED ON THE CIOMS FORM THAT A PATIENT RELATIVE STATED THAT IN (B)(6) 2023, THE CHARGING BUTTON ON THE FIRST BREELIB DEVICE FLICKERED AND WHEN LEFT CHARGING, THE DEVICE CONTINUED TO EXHIBIT THIS ISSUE. WHEN POWER UP WAS ATTEMPTED, THE GREEN BUTTON STAYED ON, AND THE PATIENT FELT THAT NEBULISATION HAD BECOME MORE DIFFICULT. IT WAS REPORTED THAT WHEN THIS DEVICE WAS CHANGED, THE SAME ISSUE OCCURRED AGAIN IN (B)(6) 2024, FOLLOWING WHICH IT WAS CHANGED AGAIN WITH ANOTHER DEVICE DELIVERED IN (B)(6) AND THE SAME FAULTS AS WITH THE PREVIOUS DEVICES HAD ALSO OCCURRED FOR A WEEK. FURTHERMORE, IT WAS REPORTED THAT THE DEVICE DOESN'T COME ON WHEN THEY RESTART IT. DURING THE FOLLOW-UP CONTACT THAT WAS MADE WITH THE PATIENT, THE PATIENT'S RELATIVE STATED THAT THEY CHANGED THE CONSUMABLES (NEBULISER HEAD AND MOUTHPIECE) ON (B)(6) 2024 AND THE DEVICE NEBULISED THE ENTIRE AMOUNT OF THE MEDICINAL PRODUCT ON (B)(6) 2024. FROM (B)(6) 2024 UNTIL (B)(6) 2024, THE DEVICE STARTED TO FAIL AND NEBULISED A PARTIAL AMOUNT OF THE MEDICINAL PRODUCT, FINALLY ON (B)(6) 2024 THE DEVICE STOPPED WORKING COMPLETELY. ON (B)(6) 2024, THE PATIENT BEGAN TO SHOW A DETERIORATION IN THEIR HEALTH AND ON (B)(6) 2024, THEY EXPERIENCED DESATURATION (REPORTING OXYGEN SATURATION LEVELS OF 55%), WENT PURPLE (THE PATIENT'S RELATIVE CONFIRMED THIS TO BE CYANOSIS), EXPERIENCED BACK PAIN, DIZZINESS AND LOSS OF STRENGTH. IT WAS REPORTED THAT THE PATIENT MISSED 6 NEBULISATIONS SINCE (B)(6) 2024, BEFORE THEY EXPERIENCED THE EVENT OF CYANOSIS. THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT WHERE SHE WAS ADMITTED ALL DAY AND WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2024. FOLLOW-UP INFORMATION RECEIVED INDICATED THAT THE PATIENT CONTINUED TO BE HOSPITALISED BETWEEN (B)(6) 2024 BUT RESTARTED NEBULISATIONS WITH A NEW BREELIB DEVICE ON (B)(6) 2024 WHILST BEING HOSPITALISED. IT IS NOTED THAT WHILST BEING HOSPITALISED, THE PATIENT WAS ADMINISTERED BOSENTAN AND SILDENAFIL. THE REPORTED CLINICAL OUTCOME OF CENTRAL CYANOSIS (PATIENT TURNED PURPLE), OXYGEN DESATURATION (SATURATION <60%) LEADING TO HOSPITALISATIONS WERE ASSESSED AS SERIOUS IN NATURE, BY VECTURA, MEETING THE DEFINITION OF 'SERIOUS INJURY' AND SUBSEQUENTLY A 'MDR REPORTABLE EVENT' PER 21CFR 803.3. THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED TO VECTURA FOR INVESTIGATION AT THE TIME OF THIS REPORT. EFFORTS ARE BEING MADE BY (B)(4) TO RETRIEVE THE DEVICE FROM THE PATIENT, SHOULD IT BE AVAILABLE FOR INVESTIGATION. RESPONSES RECEIVED ON FOLLOW-UP QUERIES REGARDING DEVICE USE AND HANDLING RESULTED IN THE FOLLOWING FINDINGS RELATING TO POOR PATIENT TECHNIQUE: THE PATIENT HAD BEEN CLEANING THE DEVICE AND CONSUMABLES USING PURIFIED WATER INSTEAD OF DISTILLED WATER (AS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE). THE PATIENT MAY HAVE BEEN PERFORMING "THE BREATHING PROCESS POORLY" FOR 1 YEAR SINCE STARTING THE PROCESS WITH BREELIB. HOWEVER, THIS CANNOT BE CONFIRMED UNTIL THE DEVICE IS RETURNED TO VECTURA FOR INVESTIGATION. QUALITY INVESTIGATION CONDUCTED INTO THIS INCIDENT TO-DATE HAS BEEN BASED ON REVIEW OF PATIENT REPORTED INFORMATION FOR THIS CASE, VERSUS ANY POTENTIALLY SIMILAR COMPLAINTS (USING KEY WORD SEARCHING OF VECTURA RECORDS) AND REVIEW OF THE DEVICE HISTORY RECORD. THE INVESTIGATION REVEALED THAT ALL UNITS THAT BELONG TO THE SAME BATCH AS THE DEVICE IN QUESTION HAD PASSED THE FUNCTIONAL TESTS BEFORE RELEASE TO THE MARKET. THE INVESTIGATION CONCLUDED THAT THE LIKELY ROOT CAUSE OF THE REPORTED 'DEVICE FAILURE' WAS USE ERROR (POTENTIAL LIQUID INGRESS INTO THE DEVICE RESULTING IN MALFUNCTION DUE TO INCORRECT CLEANING TECHNIQUE). A FULL INVESTIGATION OF THE ACTUAL DEVICE WOULD BE REQUIRED TO CONFIRM THIS HYPOTHESIS AND THE ALLEGED DEVICE FAILURE. AT THE TIME OF THIS REPORT, THE COMPLAINT COULD NOT BE CONFIRMED. AS THE PATIENT HAD REPORTED THAT DUE TO THE LACK OF THE DEVICE SHE HAS NOT BEEN ABLE TO HAVE CONTINUITY OF THE TREATMENT AND HAS EXPERIENCED A SERIOUS CLINICAL OUTCOME AND AS VECTURA HAS BEEN UNABLE TO DEFINITIVELY RULE OUT A CAUSAL/ CONTRIBUTORY LINK BETWEEN THE ALLEGED DEVICE ISSUE AND THE CLINICAL OUTCOME, IT HAS BEEN DETERMINED THAT THE EVENT MEETS THE MINIMUM CRITERIA FOR REPORTING BASED ON THE INFORMATION AVAILABLE TO-DATE, PER 21CFR803.3 (O). HOWEVER, THIS ASSESSMENT MAY CHANGE IF THE DEVICE WERE TO BE RETURNED TO VECTURA FOR INVESTIGATION OR FURTHER INFORMATION IS RECEIVED FROM THE PATIENT, RELATIVE OR LOCAL PHYSICIAN ATTENDING EXPANDING ON THE CLINICAL IMPACT, AND THE FINDINGS FROM THE INVESTIGATION CHALLENGE THE CURRENT ASSUMPTION REGARDING CAUSAL/ CONTRIBUTORY LINK BETWEEN THE ALLEGED DEVICE ISSUE AND THE REPORTED CLINICAL OUTCOME. BREELIB¿ IS NOT DESIGNED FOR EMERGENCY AND LIFE SUPPORT USE. THE BREELIB RISK MANAGEMENT FILE CONSIDERS THAT CHRONIC MISSED DOSES CAN RESULT IN INJURY OR IMPAIRMENT WHICH MAY REQUIRE PROFESSIONAL MEDICAL INTERVENTION. VENTAVIS® IS ADMINISTERED USING THE BREELIB BETWEEN 6- 9 TIMES PER DAY DEPENDING UPON INDIVIDUAL PATIENT NEED AND TOLERABILITY TO VENTAVIS®. VENTAVIS® IS NOT FIRST LINE THERAPY FOR PAH, WHICH IS A PROGRESSIVE, INCURABLE DISEASE THAT WILL EVENTUALLY LEAD TO RIGHT HEART FAILURE AND DEATH. VENTAVIS® IMPROVES THE CLINICAL COURSE OF PAH BUT CAN ONLY DELAY DISEASE PROGRESSION. VENTAVIS® IS GENERALLY PRESCRIBED AS PART OF A TRIPLE THERAPY FOR PAH, ALTHOUGH NO DETAILS OF CONCOMITANT MEDICATION HAVE BEEN PROVIDED FOR THIS CASE.
THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR (BAYER), WITH REF NO. CO-BAYER (B)(4) AND VECTURA REFERENCE (B)(4) ON 19-NOV-2024 CONCERNING THE BREELIB INHALATION SYSTEM. BAYER AND VECTURA HAVE A CO-PARTNER RELATIONSHIP WHERE THE BREELIB MEDICAL DEVICE (MANUFACTURED BY VECTURA) IS SUPPLIED BY BAYER TO PATIENTS TO USE WITH VENTAVIS (ILOPROST) THERAPY FOR PULMONARY ARTERIAL HYPERTENSION (PAH) MANAGEMENT IN THE EU AND LATIN AMERICAN MARKETS. BREELIB INHALATION SYSTEM IS NOT 510K CLEARED. THE REPORT IS BEING SUBMITTED TO THE US FDA AS THE BREELIB DEVICE IS A SIMILAR DEVICE TO THE 510K CLEARED FOX MOBILE DEVICE. THE CASE CONCERNS AN INCIDENT THAT OCCURRED IN COLOMBIA WITH A 60-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION REPORTED ON 19-NOV-2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS 20MCG/ML (RESPIRATORY) 6 DF AT AN UNSPECIFIED FREQUENCY, IN (B)(6) 2007. THE START DATE OF USING THE BREELIB DEVICE INVOLVED IN THIS EVENT TO ADMINISTER THE DRUG WAS GIVEN AS (B)(6) 2024 (EXACT DATE UNKNOWN). THE PATIENT STARTED USING THE BREELIB DEVICE FOR PERFORMING ILOPROST NEBULISATIONS BETWEEN (B)(6) 2023 (EXACT DATE UNKNOWN). IT WAS NOTED ON THE CIOMS FORM THAT A PATIENT RELATIVE STATED THAT IN (B)(6) 2023, THE CHARGING BUTTON ON THE FIRST BREELIB DEVICE FLICKERED AND WHEN LEFT CHARGING, THE DEVICE CONTINUED TO EXHIBIT THIS ISSUE. WHEN POWER UP WAS ATTEMPTED, THE GREEN BUTTON STAYED ON, AND THE PATIENT FELT THAT NEBULISATION HAD BECOME MORE DIFFICULT. IT WAS REPORTED THAT WHEN THIS DEVICE WAS CHANGED, THE SAME ISSUE OCCURRED AGAIN IN (B)(6) 2024, FOLLOWING WHICH IT WAS CHANGED AGAIN WITH ANOTHER DEVICE DELIVERED IN JUNE AND THE SAME FAULTS AS WITH THE PREVIOUS DEVICES HAD ALSO OCCURRED FOR A WEEK. FURTHERMORE, IT WAS REPORTED THAT THE DEVICE DOESN'T COME ON WHEN THEY RESTART IT. DURING THE FOLLOW-UP CONTACT THAT WAS MADE WITH THE PATIENT, THE PATIENT'S RELATIVE STATED THAT THEY CHANGED THE CONSUMABLES (NEBULISER HEAD AND MOUTHPIECE) ON (B)(6) 2024 AND THE DEVICE NEBULISED THE ENTIRE AMOUNT OF THE MEDICINAL PRODUCT ON (B)(6) 2024. FROM (B)(6) 2024, THE DEVICE STARTED TO FAIL AND NEBULISED A PARTIAL AMOUNT OF THE MEDICINAL PRODUCT, FINALLY ON (B)(6) 2024 THE DEVICE STOPPED WORKING COMPLETELY. ON (B)(6) 2024, THE PATIENT BEGAN TO SHOW A DETERIORATION IN THEIR HEALTH AND ON (B)(6) 2024, THEY EXPERIENCED DESATURATION (REPORTING OXYGEN SATURATION LEVELS OF 55%), WENT PURPLE (THE PATIENT'S RELATIVE CONFIRMED THIS TO BE CYANOSIS), EXPERIENCED BACK PAIN, DIZZINESS AND LOSS OF STRENGTH. IT WAS REPORTED THAT THE PATIENT MISSED 6 NEBULISATIONS SINCE (B)(6) 2024, BEFORE THEY EXPERIENCED THE EVENT OF CYANOSIS. THE PATIENT'S RELATIVE REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT WHERE SHE WAS ADMITTED ALL DAY AND WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2024. FOLLOW-UP INFORMATION RECEIVED INDICATED THAT THE PATIENT CONTINUED TO BE HOSPITALISED BETWEEN (B)(6) 2024 BUT RESTARTED NEBULISATIONS WITH A NEW BREELIB DEVICE ON (B)(6) 2024 WHILST BEING HOSPITALISED. IT IS NOTED THAT WHILST BEING HOSPITALISED, THE PATIENT WAS ADMINISTERED BOSENTAN AND SILDENAFIL. THE REPORTED CLINICAL OUTCOME OF CENTRAL CYANOSIS (PATIENT TURNED PURPLE), OXYGEN DESATURATION (SATURATION <60%) LEADING TO HOSPITALISATIONS WERE ASSESSED AS SERIOUS IN NATURE, BY VECTURA, MEETING THE DEFINITION OF 'SERIOUS INJURY' AND SUBSEQUENTLY A 'MDR REPORTABLE EVENT' PER 21CFR 803.3. VECTURA RECEIVED A DEVICE FOR INVESTIGATION RELATED TO THE EVENT, WITH THE INVESTIGATION CONCLUDING ON (B)(6) 2025 AND REVEALING THE FOLLOWING: THE DEVICE CASING WAS OPENED, AND UNIT WAS DISASSEMBLED FOR VISUAL INSPECTION OF THE INTERNAL COMPONENTS. THE FOLLOWING OBSERVATIONS WERE MADE: 1. DUST BUILD UP ON AIR VENT SEPARATOR. 2. SIGNS OF LIQUID INGRESS ON REVERSE SIDE OF MOTHER BOARD, CLOSE TO THE AIR CONTROL UNIT (ACU). 3. CRYSTALISED DRUG RESIDUE AND CONTAMINATION IN ACU INLET. 4. SIGNS OF LIQUID INGRESS ON ACU SEPARATOR AND SIGNS OF CORROSION ON THE MOTOR. 5. SIGNS OF LIQUID INGRESS ON PRESSURE SENSOR ON DAUGHTER BOARD. BASED ON LOCATION OF LIQUID INGRESS, CORROSION AND DRUG RESIDUE, IT IS SUSPECTED THAT THE MOST LIKELY CAUSE IS EXHALATION INTO DEVICE. IT IS POSSIBLE THAT LIQUID INGRESS FOUND ON MOTHERBOARD COULD HAVE CAUSED A TEMPORARY OR INTERMITTENT FAILURE REPORTED. THE REPORTED FAILURE COULD NOT BE REPRODUCED WHEN TESTED AT VECTURA. THE DEVICE WAS ABLE TO PERFORM A SELF-TEST AND COMPLETE AN INHALATION TEST WITH NO ATYPICAL OBSERVATIONS. THE DEVICE BATTERY AND CHARGER WERE ALSO TESTED BY ELECTRONICS ENGINEERING TEAM. THE INVESTIGATION CONFIRMED THAT THE BATTERY WAS WORKING AS INTENDED. THUS, THE DEVICE IS ASSUMED TO BE FULLY FUNCTIONAL. QUALITY INVESTIGATION CONDUCTED INTO THIS INCIDENT TO-DATE HAS BEEN BASED ON REVIEW OF PATIENT REPORTED INFORMATION FOR THIS CASE, REVIEW OF DEVICE HISTORY RECORD AND INVESTIGATION INTO THE ACTUAL DEVICE INVOLVED IN THE EVENT. THE INVESTIGATION HAS CONCLUDED THAT THE DEVICE LIKELY MALFUNCTIONED AS A RESULT OF LIQUID INGRESS DUE TO NON-ADHERENCE BY THE USER TO CLEANING, DISINFECTION, MAINTENANCE AND HANDLING AS HIGHLIGHTED IN THE DEVICE IFU. I.E., USE ERROR. IN LIGHT OF THE FINDINGS FROM THE INVESTIGATION, IT IS JUDGED THAT THERE IS NO CAUSAL/ CONTRIBUTORY LINK BETWEEN THE REPORTED ISSUE WITH THE DEVICE AND THE CLINICAL OUTCOME. AS SUCH, THE EVENT NO LONGER MEETS THE CRITERIA FOR REPORTING PER 21CFR 803.3 AND IS THEREFORE BEING DOWNGRADED TO A NON-REPORTABLE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267317 | BREELIB INHALATION SYSTEM | BREELIB | CAF | VECTURA GROUP LTD. | BREELIB STARTER PACK LAT1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Hospitalization | BOSENTANSILDENAFIL| BOSENTANSILDENAFIL |