AMBU SPUR II

Additional Manufacturer Narrative

THE PATIENT PRESENTED IN ASYSTOLE UPON ARRIVAL OF THE AMBULANCE AND NEVER CHANGED RHYTHM. A CAUSAL RELATIONSHIP BETWEEN THE PEDIATRIC SPUR II PRODUCT PROVIDED IN AN ADULT PACKAGE AND PATIENT OUTCOME HAS NOT BEEN ESTABLISHED. THE PEDIATRIC SPUR II WAS NEVER USED ON THE PATIENT. HOWEVER, AMBU DOES NOT HAVE DATA TO ESTABLISH THAT THE ROOT CAUSE OF THE EVENT IS SOLELY DUE TO PATIENT CONDITION. NO SAMPLES HAVE BEEN RETURNED TO AMBU, BUT PICTURES FROM THE CUSTOMER OF THE LABELS ON THE FINAL PACKAGING AND OF THE SPUR II PRODUCTS HAVE BEEN SENT TO AMBU. THE PICTURES CONFIRMED THE REPORTED FAILURE (PEDIATRIC SPUR II PACKED IN BAG LABELLED AS ADULT). BASED ON THE PROVIDED LOT NUMBER ON THE PEDIATRIC SPUR II AND THE PACKAGING, THE PRODUCTION RECORDS HAVE BEEN CHECKED. AS THERE IS APPROXIMATELY 6 YEARS BETWEEN THE MANUFACTURING DATE OF THE SPUR II AND THE MANUFACTURING DATE OF THE FINAL PACKAGING , IT IS CONSIDERED UNLIKELY THAT THE FINAL PACKAGING IS PACKED WRONGLY IN AMBU PRODUCTION LINE DUE TO SO LONG TIME OFF BETWEEN EACH OTHER. IN ADDITION, ALL SPUR II IN THEIR FINAL PACKAGING ARE SUBJECT TO BOTH VISUAL INSPECTION AND A CHECK BY WEIGHING PRIOR TO RELEASE. THE WEIGHT DIFFERENCE BETWEEN ADULT BAG AND PEDIATRIC BAG CAN BE DETECTED BY THE ELECTRONIC SCALE.

Description of Event or Problem

PROVIDER CALLED FOR CARDIAC ARREST AND PATIENT PRESENTED IN ASYSTOLE. A PROVICER GRABBED A BAG-VALVE-MASK (BVM) FOR VENTILATION AND REALIZED PEDIATRIC SIZED BVM WAS IN AN ADULT LABELED PACKAGE, PATIENT HAD NO RHYTHM CHANGES. THE PEDIATRIC SIZED BVM WAS NOT USED . THE PATIENT PRESENTED IN ASYSTOLE UPON ARRIVAL AT HOSPITAL AND NEVER CHANGED RHYTHM.