PHOENIX
Received Apr 29, 2008 · Event occurred Mar 26, 2008
Report 2087532-2008-00044 · MDR key 1144032
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Device Alarm System
- Dislodged
- Fluid/Blood Leak
- Normal
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Therapy/non-surgical treatment, aborted/stopped
- Blood Loss
Narrative
Description of Event or Problem
GAMBRO RECEIVED A COMPLAINT ON MARCH 28TH REPORTED THAT A PT'S VENOUS NEEDLE BECAME DISLODGED APPROX 1.5 HOURS INTO A ROUTINE DIALYSIS TREATMENT ON A PHOENIX MACHINE, SOFTWARE VERSION 3.34. ACCORDING TO THE FACILITY'S TECHNICAL DIR, THE PT FELT WETNESS ON HIS SHIRT AND ALERTED THE NURSING STAFF. NO ALARMS WERE GENERATED ON THE PHOENIX MACHINE. A MINOR BLOOD LOSS WAS REPORTED AND THE TREATMENT WAS DISCONTINUED. NO MEDICAL INTERVENTION OR INJURY REPORTED. THE PT WAS DISCHARGED HOME AND RETURNED FOR HIS NEXT SCHEDULED HEMODIALYSIS TREATMENT IN 2008. THE MACHINE WAS INSPECTED BY A GAMBRO TECH AND RESULTED TO BE WORKING AS PER SPECS. THE TECH AUTHORIZED THE MACHINE TO BE PLACED BACK IN SVC.