FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Aug 5, 2008 · Event occurred Jul 4, 2008
Report 2937457-2008-00007 · MDR key 1104503
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Device Alarm System
Patient
38 YR
- Chest Pain
- Breathing difficulties
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT TOWARDS THE END OF A HEMODIALYSIS TREATMENT, THE NURSE NOTICED THAT THE BLOODLINES WERE FILLED WITH AIR FROM THE ARTERIAL DRIP CHAMBER TO THE PT AND THERE WAS NO LEVEL DETECTOR ALARM. THE MACHINE THEN GAVE A VENOUS PRESSURE ALARM AS SOON AS THE PROBLEM WAS OBSERVED. THE PT C/O SHORTNESS OF BREATH AND CHEST PAIN. THE PT WAS PLACED IN TRENDELENBERG POSITION AND OXYGEN WAS ADMINISTERED. THE PT WAS TAKEN TO THE HOSPITAL. SHE HAS BEEN DISCHARGED SINCE AND HAS RESUMED OUTPATIENT HEMODIALYSIS TREATMENTS.
Additional Manufacturer Narrative
DEVICE WAS CHECKED BY THE FACILITY TECHNICIAN AND BY FRESENIUS. NO PROBLEM WAS FOUND IN BOTH INVESTIGATIONS. THE LEVEL DETECTOR WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF INVESTIGATION REVEALS NEW INFO.