InjuryFII
MDR event
Received Mar 14, 2008
Report 9616240-2008-00015 · MDR key 1014977
Device
Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
Not reported
- Cardiac Arrest
- Congestive Heart Failure
- Death
- Respiratory arrest
- Resuscitation
- Loss of consciousness
- Diaphoresis
- Loss Of Pulse
- Hospitalization required
Narrative
Additional Manufacturer Narrative
FACILITY NURSE MANAGER REPORTED THAT THE PT'S OFFICIAL CAUSE OF DEATH WAS RESPIRATORY ARREST SECONDARY TO SEVERE CORONARY ARTERY DISEASE (CAD) AND CONGESTIVE HEART FAILURE (CHF). FOLLOWING A THOROUGH INVESTIGATION BY THE FACILITY AND BASED ON PHYSICIAN INFO AVAILABLE, THERE IS NO REASON TO SUSPECT THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS PT'S DEATH, AS THIS PT WAS GRAVELY ILL PRIOR TO THIS EVENT.