PHOENIX
Received May 22, 2008 · Event occurred Apr 11, 2008
Report 2087532-2008-00051 · MDR key 1055552
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Normal
- Replace
Patient
15 YR
- Cramp(s)
- Electrolyte Imbalance
- Discomfort
- Treatment with medication(s)
Narrative
Description of Event or Problem
ON 04/16/08, A CUSTOMER REPORTED TO GAMBRO THAT TWO PATIENTS EXPERIENCED ELECTROLYTE IMBALANCE, WHILE DIALYZING ON THE PHOENIX MACHINE AND SOFTWARE VERSION 3.34. (FOR THE FIRST EVENT REFER TO MDR 9616240-2008-00030). ONE HALF HOUR TREATMENT THE PT BEGAN "FEELING BAD" AND CRIED OUT. THE PT RECEIVED A 100 ML IV BOLUS OF SALINE. THE FINAL DIALYSATE CONDUCTIVITY WAS CHECKED AND FOUND TO BE LOW. THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS RETURNED TO THE PT, LAB WORK WAS DRAWN WHICH REVEALED AN ELECTROLYTE IMBALANCE. TREATMENT WAS CONTINUED ON ANOTHER MACHINE AND THE PT WAS DISCHARGED HOME IN NO ACUTE DISTRESS.