BREELIB INHALATION SYSTEM
Report
- Report Number
- 3008702754-2024-06548
- Event Type
- Injury
- Date Received
- June 6, 2024
- Date of Event
- April 25, 2024
- Report Date
- July 11, 2024
- 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
THE SUSPECT DEVICE IN THIS REPORT, BREELIB IS NOT 510K CLEARED FOR USE IN THE US. THIS CASE IS BEING SUBMITTED TO THE FDA AS 'BREELIB' IS A SIMILAR MEDICAL DEVICE TO THE 510K CLEARED FOX MOBILE DEVICE. NEITHER THE FOX MOBILE OR BREELIB ARE CURRENTLY DISTRIBUTED IN THE US.
THE SUSPECT DEVICE IN THIS REPORT, BREELIB IS NOT 510K CLEARED FOR USE IN THE US. THIS CASE IS BEING SUBMITTED TO THE FDA AS 'BREELIB' IS A SIMILAR MEDICAL DEVICE TO THE 510K CLEARED FOX MOBILE DEVICE. NEITHER THE FOX MOBILE OR BREELIB ARE CURRENTLY DISTRIBUTED IN THE US.
THE INCIDENT WAS REPORTED TO THE MANUFACTURER (VECTURA) BY THE DISTRIBUTOR (BAYER), WITH REF NO. CO-BAYER 2024-024453/ 2024A065057 AND VECTURA REFERENCE (B)(4), ON (B)(6) 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 63-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED THROUGH THE CIOMS FORMS RELATING TO THE EVENT RECEIVED ON 08-MAY-2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS THERAPY FOR MANAGEMENT OF THEIR PAH AT AN UNSPECIFIED DOSE AND FREQUENCY IN (B)(6) 2021. A BREELIB NEBULIZER DEVICE WAS USED STARTING IN (B)(6) 2023. FROM (B)(6) 2021 TO (B)(6) 2024, THE PATIENT HAD RECEIVED VENTAVIS 10MCG/ML 6 INHALATIONS PER DAY. IN (B)(6) 2024, THE PATIENT EXPERIENCED HYPOXIA (CODED AS 'MEDICALLY IMPORTANT' BY BAYER) BUT THE EVENT IS NOT MEDICALLY CONFIRMED. IT IS UNCLEAR IF THE EVENT OF HYPOXIA OCCURRED BEFORE OR AFTER THE DEVICE MALFUNCTION. ON (B)(6) 2024, THE PATIENT'S MEDICINAL PRODUCT NEBULIZATION WAS SUSPENDED DUE TO A FAULTY DEVICE. THE PATIENT WAS EXPERIENCING DESATURATION [BLOOD OXYGEN], ACCORDING TO THE LATEST VERSION OF CIOMS FORM RECEIVED FROM THE DISTRIBUTOR, WHEREIN HER BLOOD OXYGEN SATURATION LEVEL WAS REPORTED AS 82% (MEASUREMENT UNCONFIRMED) AFTER SHE STOPPED INHALING THE MEDICINAL PRODUCT. THE REPORTER ALSO HIGHLIGHTED THAT THE PATIENT NORMALLY HAS A SATURATION OF BETWEEN 90 AND 92% WITH THE MEDICINAL PRODUCT. THE REPORTED CLINICAL OUTCOMES OF 'HYPOXIA' AND 'DESATURATION' WERE ASSESSED AS SERIOUS IN NATURE BY VECTURA AND AS MEETING THE DEFINITION OF 'SERIOUS INJURY' PER 21CFR 803.3. THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED TO VECTURA FOR INVESTIGATION AT THE TIME OF THIS REPORT. IT IS OUR UNDERSTANDING THAT THE DEVICE IS STILL IN THE PATIENT'S POSSESSION. EFFORTS ARE BEING MADE BY BAYER TO RETRIEVE THE DEVICE FROM THE PATIENT, 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 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 08-MAY-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 63-YEAR-OLD FEMALE PATIENT. INITIAL INFORMATION THAT WAS REPORTED THROUGH THE CIOMS FORMS RELATING TO THE EVENT RECEIVED ON 08-MAY-2024 INDICATED THAT THE PATIENT HAD STARTED VENTAVIS THERAPY FOR MANAGEMENT OF THEIR PAH AT AN UNSPECIFIED DOSE AND FREQUENCY IN (B)(6) 2021. A BREELIB NEBULIZER DEVICE WAS USED STARTING IN (B)(6) 2023. FROM (B)(6) 2021 TO (B)(6) 2024, THE PATIENT HAD RECEIVED VENTAVIS 10MCG/ML 6 INHALATIONS PER DAY. IN (B)(6) 2024, THE PATIENT EXPERIENCED HYPOXIA (CODED AS 'MEDICALLY IMPORTANT' BY BAYER) BUT THE EVENT IS NOT MEDICALLY CONFIRMED. IT IS UNCLEAR IF THE EVENT OF HYPOXIA OCCURRED BEFORE OR AFTER THE DEVICE MALFUNCTION. ON (B)(6) 2024, THE PATIENT'S MEDICINAL PRODUCT NEBULIZATION WAS SUSPENDED DUE TO A FAULTY DEVICE. THE PATIENT WAS EXPERIENCING DESATURATION [BLOOD OXYGEN], ACCORDING TO THE LATEST VERSION OF CIOMS FORM RECEIVED FROM THE DISTRIBUTOR, WHEREIN HER BLOOD OXYGEN SATURATION LEVEL WAS REPORTED AS 82% (MEASUREMENT UNCONFIRMED) AFTER SHE STOPPED INHALING THE MEDICINAL PRODUCT. THE REPORTER ALSO HIGHLIGHTED THAT THE PATIENT NORMALLY HAS A SATURATION OF BETWEEN 90 AND 92% WITH THE MEDICINAL PRODUCT. THE REPORTED CLINICAL OUTCOMES OF 'HYPOXIA' AND 'DESATURATION' WERE ASSESSED AS SERIOUS IN NATURE BY VECTURA AND AS MEETING THE DEFINITION OF 'SERIOUS INJURY' PER 21 CFR 803.3. AT THE TIME OF SUBMISSION OF THE INITIAL MEDWATCH FORM ON 06-JUN, THE DEVICE INVOLVED IN THE EVENT HAD NOT BEEN RETURNED TO VECTURA FOR INVESTIGATION. THE QUALITY INVESTIGATION INTO THE INCIDENT WAS THEREFORE BASED ON REVIEW OF PATIENT REPORTED INFORMATION, REVIEW OF POTENTIALLY SIMILAR COMPLAINTS FOR DETERMINATION OF LIKELY ROOT CAUSE, AND REVIEW OF DEVICE HISTORY RECORD. HOWEVER, ON 17-JUN, THE DEVICE INVOLVED IN THE EVENT HAD BEEN RETURNED TO VECTURA FOR INVESTIGATION. THE EVALUATION OF THE RETURNED DEVICE RESULTED IN THE FOLLOWING FINDINGS: 1. CORROSION AND CONTAMINATION WAS FOUND ON AND AROUND CONTACT PINS. 2. HEAVY DUST CONTAMINATION WAS FOUND ACROSS THE DEVICE CASING, MOUTHPIECE INLET CHANNEL, SIDE CLIPS AND MOUTHPIECE INDICATOR WINDOW. 3. DEVICE COULD BE SWITCHED ON AFTER CHARGING (DEVICE CANNOT BE SWITCHED ON IF BATTERY IS LOW). 4. BATTERY INDICATOR IS CONSTANT GREEN; DEVICE IS GOOD FOR OPERATION. 5. BLUETOOTH DATA COULD BE SUCCESSFULLY READ. THERE WERE 1694 RECORDED PATIENT USES IN TOTAL. THE FIRST PATIENT USE WAS (B)(6) 2022. THE LAST PATIENT USE WAS (B)(6) 2024. THE DEVICE WAS NOTED TO BE WITHIN MANUFACTURER'S WARRANTY. 6. THERE WERE 1600 RECORDED ERRORS IN TOTAL. THE MAIN ERROR WAS 'INHALING IN THE EXHALATION PHASE' WITH 962 ERRORS RECORDED. THERE WERE ALSO 619 ERRORS OF 'TOO LOW INHALING PRESSURE'. 7. DEVICE DID NOT PASS THE SELF-TEST. WHEN THE DEVICE WAS ASSEMBLED WITH THE GOLDEN NEBULISER HEAD (REFERENCE SAMPLE RESERVED FOR TESTING AND WHICH IS REPLACED AFTER 30 DAYS OF USE) AND SWITCHED ON, THE AUDIBLE SIGNAL COULD BE HEARD, AIR CONTROL UNIT (ACU) COULD BE HEARD TO OPEN AND CLOSE, THE MOUTHPIECE LIGHT STARTED TO FLASH ORANGE AND CONTINUED TO FLASH UNTIL THE DEVICE WAS BROKEN DOWN FOR INSPECTION OF THE INTERNAL COMPONENTRY. 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 FOUND ON AIR VENT SEPARATOR. 2. CONTAMINATION FOUND ON REVERSE SIDE OF MOTHER BOARD. 3. VERY HEAVY DRUG RESIDUE VISIBLE AROUND ACU INLET AND CORROSION ON THE ACU MOTOR. 4. SIGNS OF LIQUID INGRESS FOUND ON ACU SEAL. 5. CONTAMINATION FOUND INSIDE OF ACU INLET. 6. LIQUID INGRESS FOUND ON BOTH SIDES OF DAUGHTER BOARD IN VICINITY OF THE PRESSURE SENSOR. 7. CORROSION VISIBLE INSIDE OF ACU MOTOR. THE FINDINGS FROM THE INVESTIGATION RESULTED IN THE FOLLOWING CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED ISSUE OF DEVICE MALFUNCTION: BASED ON THE LOCATION OF LIQUID INGRESS AND DRUG RESIDUE, THE DAMAGE TO THE DEVICE ELECTRONIC COMPONENTS WAS MOST LIKELY CAUSED BY EXHALATION INTO DEVICE. THE COMPLAINT IS THEREFORE NOT ATTRIBUTABLE TO THE DEVICE AS THE IFU AND TRAINING PROVIDED TO PATIENTS CLEARLY INSTRUCT THE DEVICE IS TO BE REMOVED FROM THE MOUTH DURING EXHALATION. EXHALING INTO THE DEVICE THEREFORE CONSTITUTES A USE ERROR. IN LIGHT OF THE FINDINGS FROM THE EVALUATION OF THE RETURNED DEVICE, VECTURA HAS CONCLUDED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED CLINICAL OUTCOME. AS SUCH, THE EVENT NO LONGER MEETS THE DEFINITION OF A REPORTABLE EVENT, PER 21 CFR 803. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2934 | BREELIB INHALATION SYSTEM | BREELIB | CAF | VECTURA GROUP LTD. | BREELIB STARTER PACK LAT1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Other |