MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE

Additional Manufacturer Narrative

THE TECHNICAL SUPPORT WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. THE MANUFACTURERS RECORD WAS REVIEWED AND ALL UNITS ARE LEAK TESTED AFTER MANUFACTURE AND PRIOR TO PACKING WITH ANY PRODUCT FOUND LEAKING WILL AUTOMATICALLY REJECTED FROM THE LINE AND DISCARDED ACCORDINGLY. AS A RESULT OF TREND / REPEAT OCCURRENCES ANALYSIS A CAPA HAS BEEN RAISED WITHIN MPL FOR THE ISSUE OF DAMAGE TO MEDISORB MULTI ABSORBER AND EX CANISTERS. INVESTIGATION AND ANY ACTIONS IDENTIFIED WILL BE PROGRESSED THROUGH THE CAPA.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED THAT THE PRODUCT SAMPLE AND PHOTO IS AVAILABLE FOR ANALYSIS. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE FOR EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A COLOR INDICATOR ISSUE WITH MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE, THE SODA LIME APPEARS WHITE WHILE THE INSPIRATION INDICATES 0.5-0.9 KPA CO2, AFTER REPLACEMENT, THE CUSTOMER NOTICE A DISCREET PURPLE COLORATION. THE EVENT OCCURRED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT NO PATIENT HARM WAS ASSOCIATED ON THIS EVENT.