MDR event

Additional Manufacturer Narrative

THE PATIENT'S CAUSE OF DEATH WAS LISTED AS RESPIRATORY ARREST SECONDARY TO A PULMONARY EMBOLI. FACILITY'S NURSE MGR STATED THAT THE PHOENIX MACHINE USED ON THIS PT AT THE TIME OF DEATH DID NOT CONTRIBUTE IN ANY WAY TO THIS PT'S DEATH, BUT IT IS HER FACILITY'S POLICY TO REPORT ALL DEATHS TO THE MFR. THE COMPLAINT INVESTIGATION CONDUCTED BY GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT A GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THIS EVENT IS BEING REPORTED AS PER GAMBRO POLICY; ALL CASES OF PT DEATH WITHIN 24 HRS AFTER END OF THE TREATMENT ARE CONSIDERED REPORTABLE REGARDLESS OF ANY INVOLVEMENT OF A GAMBRO DEVICE.