GAMBRO
Received Jun 13, 2008 · Event occurred Mar 5, 2008
Report 1713683-2008-00002 · MDR key 1061119
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
70 YR
- Death
- Malaise
- Collapse
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT A PATIENT EXPIRED DURING DIALYSIS TREATMENT ON A CENTRYSYSTEM 3 MACHINE. APPROXIMATELY TWO HOURS INTO TREATMENT, THE PATIENT STATED SHE WAS NOT FEELING WELL AND COLLAPSED. INITIALLY, CLINIC STAFF BEGAN CPR, HOWEVER IT WAS DISCONTINUED DUE TO THE PATIENT'S DO NOT RESUSCITATE ORDER. THE PATIENT EXPIRED. THERE WERE NO C3 MACHINE ALARMS THROUGH THE COURSE OF TREATMENT AND CLINIC STAFF STATED THAT TREATMENT HAD BEEN UNEVENTFUL. THE DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO BE WORKING WITHIN MANUFACTURER'S SPECIFICATIONS. THERE IS NO INFORMATION THAT REASONABLY SUGGESTS ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THIS INCIDENT.
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. THIS MDR IS BEING FILED IN COMPLIANCE WITH GAMBRO POLICY, WHICH REQUIRES A FILING WHENEVER A PATIENT EXPIRES WITHIN 24 HOURS OF TREATMENT, REGARDLESS OF CAUSE. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OR RESPONSIBILITY FOR THIS INCIDENT.