Description of Event or Problem · 1
ON NOV 6 2019, RESPIRONICS NOVAMETRIX, LLC RECEIVED A MEDWATCH FILED BY (B)(6) HOSPITAL IN (B)(6) FOR PRODUCT NUMBER 1103414 CONSUMABLE AIRWAY ADAPTER SET (REF. NUMBER (B)(4)). THE PRODUCT PROBLEM STATED BY THE CUSTOMER IS THAT IN (B)(6) 2019, ¿CONDENSATION IN SAMPLE LINE LEADING TO INABILITY OF DEVICE TO RECORD A CAPNOGRAPHY READING. FREQUENTLY NEEDING TO CHANGE THIS DISPOSABLE PIECE OF EQUIPMENT.¿ UPON RECEIVING THE MEDWATCH, ATTEMPTS WERE MADE BY RESPIRONICS CLINICAL AFFAIRS TO CONTACT THE CUSTOMER VIA THE INFORMATION NOTED ON THE MEDWATCH. THE INITIAL REPORTER WAS CONTACTED BUT SHE IS AN ADMINISTRATOR IN PATIENT RELATIONS AND COULD NOT ANSWER ANY CLINICAL QUESTIONS. SHE REFERRED US TO AN ASSOCIATE IN PROCUREMENT WHO WE HAVE YET TO HEAR BACK FROM. RESPIRONICS CLINICAL AFFAIRS THEN GOT IN TOUCH WITH THE RESPIRATORY CARE DEPARTMENT AT (B)(6) BUT THE RESPIRATORY THERAPIST WAS NOT AWARE OF THE ISSUE AND COULD NOT PROVIDE ANY DETAILS OF THE EVENT. (B)(6) BIOMED DEPARTMENT WAS CONTACTED AND CONFIRMED ONLY THAT THEY USE A LOFLO SIDESTREAM MONITORING DEVICE AND ITS ACCESSORIES; THEY WERE NOT AWARE OF THE SPECIFIC ISSUE AND COULD NOT PROVIDE DETAILS OF THE PRODUCT PROBLEM. THE RISK MANAGEMENT DEPARTMENT AT THE HOSPITAL WAS ALSO CONTACTED VIA PHONE BUT NO RESPONSE WAS RETURNED. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION. (B)(6) HOSPITAL¿S LACK OF DETAILED INFORMATION SURROUNDING THE PRODUCT PROBLEM HAS MADE IT DIFFICULT TO INVESTIGATE. OUR UNDERSTANDING IS THAT THE CONSUMABLE AIRWAY ADAPTER SET ACCESSORY WAS USED ON A PATIENT WITH A C5 LOFLO DEVICE IN CONJUNCTION WITH A GE MONITOR. LOFLO IS A SIDESTREAM SAMPLING SYSTEM WITH A 50 ML/MINUTE SAMPLING RATE THAT MEASURES THE END-TIDAL CO2 OF NON-INTUBATED AND INTUBATED NEONATE, INFANT, PEDIATRIC AND ADULT PATIENTS USING SPECIALLY DESIGNED SAMPLING CANNULA AND ON-AIRWAY ADAPTER KITS. THESE KITS INCORPORATE A FILTER AND THE SAMPLE CELL THAT PROVIDES MAXIMUM FILTRATION OF FLUIDS AND CONTAMINANTS AND PROTECTS THE SYSTEM FROM ASPIRATION OF THESE FLUIDS. THE INFORMATION RECEIVED FROM THE CUSTOMER DOES NOT INDICATE THAT THE AIRWAY ADAPTER SET WAS USED WITH DEHUMIDIFICATION ACCESSORY. DESIGN SPECIFICATION FOR LOFLO ACCESSORIES (B)(4) SEC 3.5.5 STATES THAT AN ¿AIRWAY ADAPTER SAMPLING ACCESSORY WITHOUT DEHUMIDIFICATION TUBING TO WITHSTAND UP TO 12 HOURS IN A NON-HUMIDIFIED ENVIRONMENT.¿ LOFLO C5 DESIGN GUIDE (B)(4) STATES, ¿FOR HIGH HUMIDITY APPLICATIONS, A 6¿ PIECE OF DEHUMIDIFICATION TUBING IS AVAILABLE TO INSERT BETWEEN THE EXTENSION LINE AND THE PATIENT ACCESSORY¿. THE AIRWAY ADAPTER ACCESSORY IS USED IN A HIGH HUMIDITY ENVIRONMENT ON ENDOTRACHEALLY INTUBATED PATIENTS, THEREFORE IT IS EXPECTED THAT THE USEFUL LIFE OF THE ACCESSORY WILL BE SIGNIFICANTLY SHORTER WITHOUT THE DEHUMIDIFICATION TUBING. SAMPLE FLOW RATE OF THE LOFLO CO2 MODULE IS CONTINUALLY MONITORED. THE MESSAGE THAT THE LOFLO MODULE SENDS TO THE HOST SYSTEM WHEN EXPERIENCING OCCLUSION PROBLEMS IS "CHECK SAMPLE LINE" WHICH DENOTES THAT THE SAMPLE FLOW RATE OF THE MODULE HAS FALLEN OUTSIDE THE NOMINAL OPERATING RANGE FOR 15 SECONDS OR MORE. AS A RESULT, THE LOFLO CO2 MODULE WILL NOT SEND CO2 PARAMETERS TO THE HOST SYSTEM AND THE OCCLUDED TUBING WOULD NEED TO BE REPLACED. THIS IS NOT CONSIDERED A MALFUNCTION OF THE AIRWAY ADAPTER SET AS IT OPERATED AS EXPECTED.