MDR event

Additional Manufacturer Narrative

THE FACILITY'S NURSE MANAGER AND THE NEPHROLOGISTS STATED THAT THE PT'S LENGTHY AND EXTREME CARDIAC HISTORY LED TO THE PT'S DEATH. THEY ALSO BELIEVE THAT NONE OF THE GAMBRO PRODUCTS CAUSED OR CONTRIBUTED TO THIS ADVERSE EVENT. THE COMPLAINT INVESTIGATION CONDUCTED BY GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY: ALL CASES OF PT DEATH WITHIN 24 HOURS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.