MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: SAMPLE RECEIVED FOR EVALUATION. SAMPLE WAS LEAK TESTED AND ALTHOUGH IT WAS FOUND TO BE LEAKING AT 10.9ML/MIN OVER 100 CMH2O, THIS WAS WITHIN VYAIRE'S SPECIFICATION OF < 20ML/MIN IN ACCORDANCE WITH PQAS-8003138 ET AL-CA. THEREFORE NO ROOT CAUSE COULD BE DETERMINED. ALL UNITS PACKED PASSED 100% LEAK TEST AND VISUAL INSPECTION. A REVIEW OF THE BATCH DOCUMENTATION FOR LOT L01A-00256 FOUND NO ISSUES THAT COULD BE LINKED WITH DAMAGE FAILURES ON THIS BATCH. THE PALLET AND CARTON FOR CANISTERS CLEARLY STATES THAT THEY ARE FRAGILE AND TO HANDLE WITH CARE. DEVICES ARE PACKAGED IN A CARTON THAT MEETS THE VYAIRE DROP TESTING SPECIFICATION. CAPA 21-013 HAS BEEN OPENED UP DUE TO LEAK FAILURES AND THESE TYPE OF COMPLAINTS ARE BEING TRACKED ON OUR COMPLAINTS SYSTEM.

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN 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 THAT THE MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE EXPERIENCED BROKEN CARTRIDGES. THE ISSUE OCCURRED DURING PATIENT-USE AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.