InjuryFII
CENTRYSYSTEM 3
Received Sep 24, 2008 · Event occurred Apr 13, 2006
Report 1713683-2008-00004 · MDR key 1173364
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
69 YR
- Death
- Resuscitation
- Loss of consciousness
- Hospitalization required
Narrative
Description of Event or Problem
GAMBRO RECEIVED A REPORT OF A PT DIALYZING ON A C3 MACHINE WHO BECAME UNRESPONSIVE AND REQUIRED CARDIO PULMONARY RESUSITATION. THE PT WAS HOSPITALIZED AND MADE A DO NOT RESUSITATE BY FAMILY.
Additional Manufacturer Narrative
GTS AWAITING PERMISSION TO INSPECT MACHINE. THIS UNIT HAS REMAINED IN SERVICE SINCE THIS INCIDENT WITH NO FURTHER REPORTED INCIDENTS. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. GAMBRO DOES NOT REGARD TO THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF LIABILITY.