FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Apr 21, 2004 · Event occurred Mar 12, 2004
Report 2937457-2004-00007 · MDR key 522074
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care-north AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Alarm, failure of warning
- Disconnection
Patient
79 YR
- Death
- Blood pressure, low
- Hospitalization required
- Blood Loss
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT THE VENOUS LINE WAS FOUND DISCONNECTED FROM THE PT'S SUBCLAVIAN CATHETER DURING A HEMODIALYSIS TREATMENT. THERE WAS NO MACHINE ALARM. BLOOD WAS FOUND ON THE FLOOR BUT THE AMOUNT OF BLOOD LOST COULD NOT BE ESTIMATED. VENOUS PRESSURE (VP) AT 7:32 A.M. (PRIOR TO THE INCIDENT) WAS 136. AT 7:46 A.M., WHEN THE DISCONNECTION WAS DISCOVERED, THE VP READING WAS 77. THE VENOUS ALARM WIDTH SELECTED IS UNKNOWN. THE PT WAS TAKEN TO THE HOSP AND EXPIRED A FEW DAYS LATER. CONTACT DOES NOT HAVE ANY INFO AS TO THE CAUSE OF DEATH OR IF AN AUTOPSY WAS PERFORMED.