MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED YET. 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 MAJOR LEAK IN THE ANAESTHETIC MACHINE DURING AN EMERGENCY. LEAK WAS FROM A VERY VISIBLE CRACK IN THE CANISTER AND CAUSED THE PATIENT'S SATURATION TO DROP RAPIDLY. THE ANAESTHETIST HAD TO BLOW INTO THE ENDOTRACHEAL TUBE TO VENTILATE PATIENT. HOWEVER, THE HOSPITAL CONFIRMED THAT THEY HAVE NOT CHECKED THE MACHINE BEFORE USE AND CONCEDED THAT THE CANISTER MAY HAVE NOT BEEN HANDLED CORRECTLY BY THE STAFF.

Additional Manufacturer Narrative

DEVICE EVALUATION. NO PRODUCT SAMPLE HAS BEEN RETURNED FOR EVALUATION. HOWEVER, REVIEW OF THE DEVICE HISTORY RECORD REVEALS NO DEFECTS IN ANY OF THE CANISTERS. ALSO, CANISTERS ARE PACKAGED IN A CARTON THAT MEETS VYAIRE DROP TESTING SPECIFICATION AS WELL AS LABELED FRAGILE AND TO HANDLE WITH CARE. THEY ARE ALSO 100% LEAK TESTED ON THE PRODUCTION LINE AND FAILURES ARE AUTOMATICALLY REJECTED. PHOTOGRAPHIC EVIDENCE SUPPLIED IN THIS CASE CLEARLY SHOWS THAT THE CANISTERS HAVE EXTENSIVE CRACKS AND HAVE BEEN SUBJECTED TO A SIGNIFICANT IMPACT, INDICATIVE OF BEING DROPPED ONCE OUT OF THE CARTON. THE END USER REPORT STATED THAT "WE CONCEDE THAT CANISTERS MAY NOT BE HANDLED CORRECTLY BY STAFF." AS SUCH, ROOT CAUSE OF FAILURE HAS BEEN DETERMINED TO BE DAMAGE FROM DEVICE MISUSE.