POLYFLUX 24R
Received Sep 27, 2013 · Event occurred Sep 2, 2013
Report 9611369-2013-00006 · MDR key 3373280
Device
Generic name
Hemodialyzer, Re-use, High Flux
Manufacturer
Gambro Dialysatoren GmbhModel number
POLYFLUX 24 RCatalog number
104324
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
79 YR
- Cardiac Arrest
- Death
Narrative
Additional Manufacturer Narrative
THE POLYFLUX 24R INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER COULD NOT BE PROVIDED BY THE FACILITY.
Description of Event or Problem
A PATIENT WITH KNOWN CORONARY ARTERY DISEASE AND PREVIOUS ACUTE CORONARY SYNDROME CODED DURING THE DIALYSIS TREATMENT. RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. THE PATIENT'S FAMILY DECLINED AN AUTOPSY. THE REPORTED CAUSE OF DEATH WAS "ACUTE CARDIAC EVENT". THE CLINICAL COORDINATOR STATED THERE WAS NOTHING TO INDICATE ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT'S EVENT. THE PHOENIX MACHINE WAS INSPECTED AND PERFORMED PER MANUFACTURER'S SPECIFICATIONS. THE CARTRIDGE BLOOD TUBING SET, DIALYZER AND BICART WERE DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.