AMSORB PLUS

Description of Event or Problem

(B)(4). GE HEALTHCARE (TAMPEREEN YLIOPISTOLLINEN SAIRAALA (TAYS), FINLAND) RAISED AN ISSUE WITH AMAB3801GE--- (2105489-003 AMSORB® PLUS PREFILLED G-CAN® 1.0L) LOT 211223F412. THE VENTILATORS IN OPERATING ROOMS T6 AND T2A WERE CHECKED FOR LEAKS. WITH NEW ABSORBERS INSTALLED; THE MACHINES LEAKED MORE THAN 600 ML AND 500 ML RESPECTIVELY IN BOTH ORS. IN OPERATING ROOM T6, THE ABSORBER WAS REPLACED WITH A NEW ABSORBER; BUT LEAK WAS STILL MORE THAN 400 ML. THE ABSORBER HAD TO BE REPLACED AGAIN; WITH THE THIRD ABSORBER THE LEAK WAS WITHIN THE SPECIFICATION RANGE. IN OR T2A, THE ABSORBER WAS REPLACED ONCE AND THE LEAKAGE WAS WITHIN LIMITS. STORED ALL THREE ABSORBERS. CONTRIBUTING FACTORS: NORMAL CONDITIONS. BOTH OPERATING ROOMS HAD BEEN USED EARLIER IN THE DAY. THE MACHINE IN T2A HAD ACCUMULATED A LOT OF MOISTURE; ALSO, TO THE TUBING AND THE MACHINE. // CONSEQUENCES TO CUSTOMER/PATIENT: NO HARM. DEVICE WAS CONNECTED TO PATIENT. 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). THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM REPORTED. AS THIS PRODUCT IS AVAILABLE ON THE MARKET IN THE US, WE ARE OBLIGED TO REPORT TO FDA. PLEASE NOTE THAT DUE TO IT ISSUES WITH THE US PORTAL, ARMSTRONG MEDICAL LTD HAVE BEEN UNABLE TO SUBMIT REPORTS TO THE FDA UNTIL NOW.

Additional Manufacturer Narrative

NO CAPA MEASURES IMPLEMENTED AS THE DEVICE WAS NOT RETURNED TO BE ABLE TO COMPLETE A FULL ROOT CAUSE INVESTIGATION.