CURAPLEX

Additional Manufacturer Narrative

THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. THIS CAUSED A LACK OF POSITIVE PRESSURE RESULTING IN A DELAY OF RESUSCITATION EFFORTS FOR THE PATIENT. THE PATIENT IS IN CRITICAL CARE ON A VENTILATOR CURRENTLY. THE FAILURE WAS NOTED QUICKLY, AND A REPLACEMENT WAS USED FROM A BACKUP ON THE AMBULANCE.

Description of Event or Problem

THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. FAILURE WAS ON AN AMBULANCE. THE UNIT FAILURE RESULTED IN LACK OF POSITIVE PRESSURE. THE AIRWAY EMT NOTICED THIS AND CHANGED TO ANOTHER UNIT THAT IN FACT OPERATED CORRECTLY. THE ETCO2 IMPROVEMENT WAS DRAMATIC.

Description of Event or Problem

THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. FAILURE WAS ON AN AMBULANCE. THE UNIT FAILURE RESULTED IN LACK OF POSITIVE PRESSURE. THE AIRWAY EMT NOTICED THIS AND CHANGED TO ANOTHER UNIT THAT IN FACT OPERATED CORRECTLY. THE ETCO2 IMPROVEMENT WAS DRAMATIC.

Additional Manufacturer Narrative

THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. THIS CAUSED A LACK OF POSITIVE PRESSURE RESULTING IN A DELAY OF RESUSCITATION EFFORTS FOR THE PATIENT. THE PATIENT IS IN CRITICAL CARE ON A VENTILATOR CURRENTLY. THE FAILURE WAS NOTED QUICKLY, AND A REPLACEMENT WAS USED FROM A BACKUP ON THE AMBULANCE. **UDI RELATED DATA QUALITY UPDATES** IN ADDITION, INVESTIGATION WAS COMPLETED WITH THE FOLLOWING UPDATES: THE COMPLAINT OF "THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG." REGARDING PART NUMBER 2442-BVMPSA/LOT 363395 WAS NOT CONFIRMED AS THERE WAS NO RETURNED PRODUCT, PICTURES OR VIDEO TO EVALUATE. THIS COMPLAINT COULD POTENTIALLY BE RELATED TO A LOOSE DIAPHRAGM VALVE WITHIN THE BAG BODY THAT WAS NOT ASSEMBLED CORRECTLY AND BECAME LOOSE PRIOR TO END-USE. THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO ABNORMAL PROCESSING ISSUES NOTED RELATED TO THIS COMPLAINT; THE TAIL VALVE ASSEMBLY (PN 3010007) WAS FROM LOT NUMBERS 220700087 AND 220600023, AND THOSE LOTS PASSED INSPECTION. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE HIGH WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD; THE COMPLAINT WAS SUBMITTED TO CARB. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REGARDING PART NUMBER 2442-BVMPSA FOR THE SAME ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A MEMO, CONTAINING THE COMPLAINT INVESTIGATION, WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.