MICROGARD II BACT/VIRAL FILTER
Report
- Report Number
- 9615102-2024-00149
- Event Type
- Malfunction
- Date Received
- June 19, 2024
- Date of Event
- June 15, 2023
- Report Date
- June 19, 2024
- Manufacturer
- VYAIRE MEDICAL GMBH
- Product Code
- CAH
- UDI-DI
- 14250892903115
- PMA / PMN Number
- K111408
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 003
Narratives
IT WAS DETERMINED THAT THE STATEMENT OF THE SUPPLIER WASN'T FITTING TO THE TYPE OF THIS COMPLAINT. IT WAS ASSUMED THAT A MISSING FILTER FLEECE WOULD HAVE THE SAME MITIGATION MEASURES FOR EACH PRODUCTION LINE AS A MISPLACED FILTER LINING. THEREFORE, THE SUPPLIER (B)(4). WAS CONTACTED AGAIN FOR A MORE SPECIFIC STATEMENT. THE SUPPLIER IMPLEMENTED THE FOLLOWING IMPROVEMENTS TO REDUCE THE PROBABILITY OF OCCURRENCE OF MISPLACED FILTER LININGS: THE MANUFACTURER OF THE FILTER CARRIED OUT A MACHINE RETROFIT IN THE PERIOD 09/2022. THIS MEASURE RESULTED IN AN IMPROVED QUALITY OF THE RAW NONWOVEN, WHICH SIGNIFICANTLY REDUCES THE DETACHMENT / SLIPPING OF THE COVER NONWOVEN. THE SUPPLIER CHECKED, CHANGED AND ADJUSTED THE SETTINGS ON THEIR INTERNAL MACHINES, ESPECIALLY THE MONITORING SYSTEM, IN ORDER TO IMPROVE THE EJECTION OF FAULTY PARTS. AS THE ERROR OF A SLIPPING FILTER CANNOT BE COMPLETELY RULED OUT AFTER THE ABOVE MEASURES, THE SUPPLIER IS CURRENTLY WORKING ON AN IMPROVED CAMERA SYSTEM. THIS PROJECT IS ALREADY AT AN ADVANCED STAGE.
THIS REPORT IS SUBMITTED LATE BECAUSE IT WAS ORIGINALLY ASSUMED THAT THE MISPLACED FILTER LINING WOULD BE OBVIOUS TO THE CUSTOMER AND COULD NOT BE OVERLOOKED. AFTER RE-ASSESSING THE COMPLAINT, IT WAS DECIDED TO CLASSIFY THE INCIDENT AS A REPORTABLE EVENT. A CLINICAL RISK ASSESSMENT RESULTED IN A POSSIBLE CRITICAL SEVERITY OF HARM. THE PROBABILITY OF THE SITUATION LEADING TO THE HARM (P2) IS SOMEWHAT LIKELY. THUS, THIS MALFUNCTION IS REPORTABLE TO THE FDA AS IT IS NOT UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. TWO MICROGARD FILTERS (LOT RH 221377, EXPIRY DATE 2025-05-02 AND RH 223062, EXPIRY DATE 2025-09-03) HAVE BEEN DELIVERED TO THE CUSTOMER WITH A MISPLACED FILTER LINING. THE MISPLACEMENT IS OBVIOUS FOR THE CUSTOMER. THEREFORE THE COMPLAINT COULD BE CONFIRMED AND THE ROOT-CAUSE CAN BE ATTRIBUTED TO MANUFACTURING / SUPPLIER QUALITY ISSUE. THE DEFECTIVE FILTER WERE RETURNED TO VYAIRE FOR AN EVALUATION AND THE CUSTOMER RECEIVED A REPLACEMENT. THE SUPPLIER RIENSCH & HELD GMBH & CO. KG. PROVIDED A STATEMENT REGARDING THE MITIGATION MEASURES FOR EACH PRODUCTION LINE. IT HAS BEEN CONFIRMED THAT ALL THREE PRODUCTION LINES HAVE BUILT-IN AND EFFECTIVE MITIGATION MEASURES TO AVOID THE PRODUCTION FROM FILTERS WITHOUT BACTERIAL/VIRAL FILTER INLAY. NO SCAR NECESSARY FOR SUPPLIER RIENSCH & HELD GMBH & CO. KG. CORRECTIVE AND PREVENTIVE ACTIONS WERE IMPLEMENTED BY THE SUPPLIER ON 01/26/2022. THE AFFECTED FILTER WAS PRODUCED BEFORE THE IMPLEMENTATION DATE. ALL OTHER PRODUCTION LINES PRODUCED MICROGARD FILTERS WITHIN SPECIFICATIONS.
THE CUSTOMER COMPLAINED THAT THE FILTER-LINING OF THE MICROGARD FILTER IS MISPLACED. THIS WAS NOTICED DURING AN INCOMING INSPECTION. THERE WAS NO INDICATION THAT DEFECTIVE FILTERS WERE USED FOR PATIENT MEASUREMENTS.
THE CUSTOMER COMPLAINED THAT THE FILTER-LINING OF THE MICROGARD FILTER IS MISPLACED. THIS WAS NOTICED DURING AN INCOMING INSPECTION. THERE WAS NO INDICATION THAT DEFECTIVE FILTERS WERE USED FOR PATIENT MEASUREMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702215 | MICROGARD II BACT/VIRAL FILTER | FILTER, BACTERIAL, BREATHING-CIRCUIT | CAH | VYAIRE MEDICAL GMBH | MICROGARD II BACT/VIRAL FILTER | RH221377; RH223062 | 14250892903115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |