AMSORB PLUS

Additional Manufacturer Narrative

ARMSTRONG MEDICAL LTD CONSIDER THIS CASE TO BE CLOSED.

Description of Event or Problem

ARMSTRONG MEDICAL LTD RECEIVED A REPORT FROM GE HEALTHCARE (B)(4); (SIMILAR TO (B)(4) ON 31-OCT-2025. THE CUSTOMER, PCS CLINICAL ACCESSORIES (B)(6) FRANCE), RAISED AN ISSUE OCCURRING AT TWO DIFFERENT HOSPITALS WITH AMAB3801GE--, AMSORB PLUS PREFILLED G-CAN ABSORBER CANISTER, 1.0L, BOX OF 8 FOR THE SAME LOT 080425F211. LEAKS HAVE BEEN DETECTED ON ALL CUSTOMER BATCHES OF THESE SODA LIME CANISTERS. 3 BOXES CONCERNED LOT: 080425F211. PATIENT INVOLVEMENT BUT NO HARM REPORTED. ARMSTRONG MEDICAL LTD REQUESTED RETURN OF THE DEVICES, BUT THEY WERE NOT AVAILABLE TO RETURN. ARMSTRONG MEDICAL LTD WERE THEREFORE UNABLE TO INVESTIGATE A ROOT CAUSE RESULTING IN NO CORRECTIVE OR PREVENTIVE ACTION BEING DETERMINED OR IMPLEMENTED. ARMSTRONG MEDICAL WILL CONTINUE TO MONITOR THESE DEVICES AS PART OF OUR POST-MARKET SURVEILLANCE AND VIGILANCE ACTIVITIES. NOTE THAT THIS EVENT OCCURRED IN FRANCE, AS THE DEVICE IS AVAILABLE ON THE MARKET IN US, WE ARE OBLIGED TO NOTIFY THE FDA AS PER MDSAP REQUIREMENTS. AS THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM, ARMSTRONG MEDICAL LTD CONSIDER THIS TO BE A REPORTABLE EVENT AS IT MEETS ALL THREE BASIC REPORTING CRITERIA A-C OF MEDDEV 2 12-1 REV.8 AND MDR ARTICLE 2 (65).