FRESENIUS DIALYSIS DELIVERY SYSTEM
Received Nov 8, 2005 · Event occurred Oct 7, 2005
Report 2937457-2005-00019 · MDR key 645557
Device
Generic name
Hemodialysis Machine
Manufacturer
Fresenius Medical Care North AmericaModel number
2008KCatalog number
NA
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
38 YR
- Low Blood Pressure/ Hypotension
- Chest Tightness/Pressure
- Hospitalization required
Narrative
Description of Event or Problem
A DIALYSIS FACILITY REPORTED THAT AFTER A HEMODIALYSIS TREATMENT WAS COMPLETED, THE PATIENT FELT SOMETHING HOT GO UP HIS ARM AND INTO HIS CHEST. A POCKET OF AIR ABOUT 3 IN. IN LENGTH WAS NOTED IN THE VENOUS FISTULA NEEDLE. THE STAFF DOES NOT REMEMBER IF THERE WAS ANY AIR IN THE BLOODLINES. THE PATIENT WAS PLACED IN TRENDELENBURG POSITION AND OXYGEN WAS ADMINISTERED. THE PATIENT BECAME HYPOTENSIVE AND C/O CHEST TIGHTNESS. HE WAS TAKEN TO THE HOSPITAL AND WAS DISCHARGED LATER. PRELIMINARY DIAGNOSIS WAS EITHER A MILD HEART ATTACK OR AIR EMBOLISM.