PHOENIX
Received May 27, 2008 · Event occurred Apr 11, 2008
Report 2087532-2008-00050 · MDR key 1057121
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Normal
- Unknown (for use when the device problem is not known)
Patient
17 YR
- Headache
- Nausea
- Seizures
- Seizures, Grand-Mal
- Cramp(s)
- Electrolyte Imbalance
- Therapy/non-surgical treatment, additional
- Blood pressure, decreased
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
ON 4/16/08 A CUSTOMER REPORTED TO GAMBRO THAT TWO PTS EXPERIENCED ELECTROLYTE IMBALANCE, WHILE DIALYZING ON THE PHOENIX MACHINE AND SOFTWARE VERSION 3.34. (FOR THE SECOND EVENT REFER TO MDR 9616240-2008-00031): DURING TREATMENT THE PT COMPLAINED OF SEVERE CRAMPING, HEADACHE, NAUSEA ALONG WITH A DECREASE IN BLOOD PRESSURE. THE PT WAS ADMINISTERED OXYGEN, RECEIVED IV BOLUSES OF SALINE, IV ANTIEMTIC, AND ORAL ACETAMINOPHEN. FOLLOWING TREATMENT THE PT HAD A SEIZURE AND WAS ADMITTED TO THE PICU FOR 48 HOURS AND THEN DISCHARGED HOME.