LIBERATOR

Additional Manufacturer Narrative

PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2010. LIBERATOR STATIONARY LOX UNIT CBB3010310113, PRODUCED IN 2010, WAS EVALUATED ACCORDING TO A PEER-REVIEWED TEST PROTOCOL. THE UNIT PASSED ALL TEST SECTIONS, INCLUDING EVENT REPLICATION. THE EVENT COULD NOT BE REPLICATED AND THE CAUSE OF THE EVENT AS DESCRIBED COULD NOT BE DETERMINED. CAIRE IS NOT THE HOLDER OF THE CE MARKING FOR THE RECOMMENDED CANNULA OR ANY CANNULA THAT MIGHT HAVE BEEN IN USE AT THE TIME OF THE EVENT. THE UNIT SHOWED SIGNS OF TYPICAL WEAR ON THE DEWAR AND QUICK DISCONNECT VALVES. THERE WAS NO QUICK DISCONNECT VALVE (QDV) CLEANING KIT ATTACHED TO THE UNIT WHEN RECEIVED FOR THE INVESTIGATION, AND THE TOP FILL QUICK DISCONNECT VALVE CAP WAS MISSING. THESE LATTER TWO ITEMS ARE TYPICALLY ATTACHED TO THE UNIT VIA A CHAIN. AN EVENT REPLICATION TEST WAS PERFORMED AT THE REPORTED 2.5 LPM SETTING USING THE CANNULA RECOMMENDED IN THE USER MANUAL. THE PATIENT CANNULA IN USE AT THE TIME OF THE EVENT WAS NOT RETURNED FOR EVALUATION. AMBIENT, CANNULA BARB, AND CANNULA OUTLET TEMPERATURE MEASUREMENTS WERE TAKEN AT STANDARD INTERVALS. CANNULA BARB AND OUTLET TEMPERATURES REMAINED ABOVE FREEZING, AVERAGING 11ºC. THE EVENT WAS NOT REPLICATED. TESTING DID NOT ESTABLISH THAT THE REPORTED RASH BETWEEN THE EYES AND NOSE WAS A CRYOGENIC BURN CAUSED BY DISCHARGE OF LIQUID OXYGEN FROM THE CANNULA OR FROM THE UNIT. THE OBSERVATION AS REPORTED IS NOT APPLICABLE TO CAIRE'S DEVICE. LIBERATOR RISK ASSESSMENT SLOX-RA-001 REV S WAS REVIEWED AND DEEMED ADEQUATE WITHOUT REVISION. THE RISK FILE AND USE INSTRUCTIONS ADDRESS POTENTIAL CAUSES OF TEMPORARY FROST OR ICING AND PROPER PREVENTIVE MAINTENANCE.

Description of Event or Problem

AS REPORTED: "THE PATIENT REPORTS THAT THE LBU [LIQUID BASE UNIT] IS FROZEN AND COLD OXYGEN IS COMING OUT OF THE NASAL CANNULA. THE LPU [LIQUID PORTABLE UNIT] WAS NOT FILLED. WHEN PICKING UP THE LBU, THE DRIVER NOTICES THAT THE PATIENT HAS A RASH BETWEEN THE EYES AND NOSE. THE PATIENT COMPLIED WITH THE PRESCRIBED CONSUMPTION OF 2.5 LITRES. IT IS UNCLEAR WHETHER THE RASH WAS CAUSED BY THE COLD, BY THE MATERIAL INTOLERANCE OR BY BOTH. AS A PRECAUTION, THE PATIENT IS SWITCHED TO A DIFFERENT NASAL CANNULA. THE LBU WAS PICKED UP AND IT WAS FOUND TO BE HEAVILY ICED UNDER THE LID."

Additional Manufacturer Narrative

PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2010. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.