SYNCLARA COUGH SYSTEM

Additional Manufacturer Narrative

THE BAXTER TECHNICAL SUPPORT FOUND THE PATIENT CIRCUIT KIT NEEDED TO BE REPLACED. THE SYNCLARA COUGH SYSTEM IS INTENDED FOR USE ON PATIENTS WHO ARE UNABLE TO COUGH OR CLEAR SECRETIONS EFFECTIVELY DUE TO REDUCED PEAK COUGH EXPIRATORY FLOW OR RESPIRATORY MUSCLE WEAKNESS. THE SYNCLARA COUGH SYSTEM PROVIDES A NONINVASIVE THERAPY DESIGNED FOR USE BY PATIENTS, CAREGIVERS, AND HEALTHCARE PROVIDERS. THE SYSTEM WILL SIMULATE A COUGH TO REMOVE SECRETIONS IN PATIENTS WITH A COMPROMISED PEAK COUGH FLOW. POSSIBLE ADVERSE CONDITIONS LISTED IN THE DEVICE INSTRUCTIONS FOR USE INCLUDE SWALLOWING TOO MUCH AIR RESULTING IN THE LIKELIHOOD OF VOMITING AND ASPIRATION. THE USE OF A FACE MASK MAY RESULT IN DISCOMFORT, VOMITING, OR BREATHLESSNESS IN SOME PATIENTS. CLOSE SUPERVISION THROUGHOUT THE TREATMENT IS NECESSARY WHEN THIS PRODUCT IS USED BY CHILDREN OR PATIENTS WITH PHYSICAL LIMITATIONS OR IMPAIRED COGNITIVE ABILITIES. A SEARCH OF THE BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS PRODUCT. IT IS UNKNOWN IF THE CUSTOMER PERFORMS PREVENTATIVE MAINTENANCE ON THEIR PRODUCTS. A REPLACEMENT PATIENT CIRCUIT KIT WAS SENT TO THE CUSTOMER. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF A BROKEN FILTER WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT (B)(6) NON-FT SW,HC,NA HAD FILTER BROKEN. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.