PHOENIX
Received Sep 4, 2008 · Event occurred Jul 29, 2008
Report 2087532-2008-00090 · MDR key 1150163
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
54 YR
- Respiratory Distress
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- Hospitalization required
- Blood Loss
Narrative
Description of Event or Problem
FACILITY CHIEF MEDICAL DIR REPORTED THAT A CHRONIC HEMODIALYSIS PT SUFFERED A SEVERE REACTION AT THE BEGINNING OF A ROUTINE DIALYSIS TREATMENT ON A PHOENIX MACHINE. APPROX 16 MINUTES INTO HIS HEMODIALYSIS TREATMENT, THE PT PRESENTED WITH SEVERE RESPIRATORY DISTRESS REQUIRING IV EPINEPHRINE, METHYLPREDNISOLONE, BENADRYL AND ADMINISTRAITON OF OXYGEN. THE PT'S BLOOD WAS NOT RETURNED RESULTING IN A 218 ML BLOOD LOSS. THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION, DISCHARGED THE NEXT DAY AND IS NOW DIALYZING IN THE CHRONIC DIALYSIS UNIT. THIS PARTICULAR MACHINE WAS USED DURING THE FIRST SHIFT ON THE DAY OF THIS INCIDENT WITHOUT REPORTED PROBLEMS.