InjuryFII
PHOENIX
Received Mar 14, 2008 · Event occurred Feb 11, 2008
Report 2087532-2008-00028 · MDR key 1015166
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
- Defective Component
Patient
77 YR
- Low Blood Pressure/ Hypotension
- Sepsis
- Loss of consciousness
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
A CLINIC REPORTED THAT PRIOR TO INITIATING TREATMENT A PT WAS UNUSUALLY HYPERTENSIVE AND BECAME UNRESPONSIVE ONE HOUR AND TWENTY MINUTES INTO TREATMENT. TREATMENT WAS TERMINATED, SALINE WAS ADMINISTERED AND THE PT WAS TRANSPORTED TO THE HOSP WHERE SHE SUFFERED A CARDIAC ARREST. FOLLOWING THE HOSPITALIZATION, THE PT WAS DISCHARGED HOME AND RETURNED TO OUTPATIENT DIALYSIS TREATMENT. THE MACHINE WAS RETURNED TO SERVICE FOLLOWING INSPECTION BY A GAMBRO GTS REPRESENTATIVE.