Description of Event or Problem · 1
THE HOSPITAL WAS USING A HUMIDIFIER ADAPTER AND A STERILE WATER INHALATION SOLUTION WITH A NASAL CANNULA ON A PREMATURE INFANT. THE OXYGEN FLOW WAS SET AT 0.25 LITERS PER MINUTE (THE LABEL REQUIRES THE FLOW BE SET ON 4.0 LITERS PER MINUTE) AND THE HUMIDIFIER ADAPTER WAS NOT TESTED FOR AUDIBLE ALARM PRIOR TO PT SET-UP. THE LABELING INDICATES THE HUMIDIFIER ADAPTER MUST BE TESTED FOR AUDIBLE ALARM BEFORE USE AND THE HOSPITAL INDICATED THIS WAS NOT THE NASAL CANNULA TUBING CRIMPING THE OXYGEN SUPPLY TO THE INFANT. DUE TO THE LOW FLOW RATE, THE HUMIDIFIER ADAPTER DID NOT ALARM. A HEART MONITOR ALERTED A NURSE, TO A LOWERED HEART RATE, AND SHE IMMEDIATELY MOVED THE CART. THE HOSPITAL STATED THAT AFTER THE INCIDENT THERE WERE NO ADVERSE AFFECTS TO THE INFANT. AFTER THE INCIDENT, THE HUMIDIFIER ADAPTER WAS TESTED FOR AUDIBLE ALARM AT 0.25 LITERS PER MINUTE AND DID NOT ALARM, BUT WHEN THE FLOW WAS INCREASED TO THE CORRECT OPERATING PARAMETER OF 4.0 LITERS PER MINUTE, THE ALARM FUNCTIONED PROPERLY. HOSPITAL HAS NO RECORD OF THE LOT NUMBER OF THE HUMIDIFIER ADAPTER, NOR THE HUMIDIFIER ADAPTER SAMPLE FROM THE INCIDENT. IN ADDITION, ALL HUMIDIFIER ADAPTER SAMPLES FROM THEIR INVENTORY WERE DISCARDED. AS SUCH, AN INTERNAL INVESTIGATION, AT CO, CANNOT BE INITIATED. ALTHOUGH THE HUMIDIFIER ADAPTER FUNCTIONED PROPERLY WHEN USED AS INDICATED BY THE LABELING, CO IS REPORTING THIS INCIDENT AS A 30 DAY MDR PER 21 CFR 803.3 (D)(6) USER ERROR. IT IS THE CO'S UNDERSTANDING THE HOSPITAL IS NOW USING HUMIDIFIER ADAPTERS THAT OPERATE IN THE MORE APPROPRIATE LITER PER MINUTE FLOW RANGE REQUIRED FOR INFANTS. THERE WILL BE NO F/U INFO, THIS IS A FINAL REPORT.