GAMBRO

Description of Event or Problem

THE CUSTOMER REPORTED THAT A PT WAS ON A CENTRYSYSTEM MACHINE AND BEGAN EXPERIENCING RESPIRATORY DIFFICULTIES. THE PATIENT'S BLOOD WAS RETURNED TO HIM, BUT HIS CONDITION DETERIORATED. THE PATIENT'S HEART STOPPED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT WAS TRANSPORTED, VIA AMBULANCE, TO THE EMERGENCY DEPT WHERE HE EXPIRED SHORTLY AFTER ARRIVING. THE DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO BE WORKING WITH MANUFACTURER'S SPECIFICATIONS. THE MEDICAL DIRECTOR DOES NOT BELIEVE THAT ANY GAMBRO DEVICE BEING USED DURING THIS TREATMENT CAUSED OR CONTRIBUTED TO THIS PATIENT'S DEATH.

Additional Manufacturer Narrative

GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE MACHINE WAS INSPECTED AND WAS FOUND TO BE OPERATING WITHIN MANUFACTURER'S SPECIFICATIONS. THE PATIENT HAD AN EXTENSIVE HISTORY OF CORONARY ARTERY DISEASE AS WELL AS A HISTORY OF FREQUENT EPISODES OF INTRADIALYTIC HYPOTENSION. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF RESPONSIBILITY FOR THE INCIDENT. THE EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PATIENT'S DEATH WITHIN 24 HOURS AFTER THE END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE .