PHOENIX
Received Mar 14, 2008 · Event occurred Feb 14, 2008
Report 2087532-2008-00029 · MDR key 1014962
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
86 YR
- Cardiac Arrest
- Congestive Heart Failure
- Death
- Respiratory arrest
- Resuscitation
- Loss of consciousness
- Diaphoresis
- Loss Of Pulse
- Hospitalization required
Narrative
Description of Event or Problem
A CLINIC REPORTED THAT AN ACUTE DIALYSIS NURSE WAS TRAINING WHICH A GAMBRO RENAL THERAPY SPECIALIST ON NEW PHOENIX MACHINES WHEN IT WAS OBSERVED THAT A PT SUDDENLY BECAME DIAPHORETIC AND NON-RESPONSIVE ONE HOUR AND 45 MINUTES INTO A THREE-HOUR TREATMENT. AT THAT TIME, THE PT CONTINUED TO HAVE SPONTANEOUS RESPIRATIONS AND A PALPABLE PULSE. HOWEVER, AFTER A MINUTE OR TWO, THE PT CEASED BREATHING AND BECAME PULSELESS. PATIENT CODED AND WAS SUCCESSFULLY RESUSCITATED AND TRANSFERRED TO THE INTENSIVE CARE DEPT, BUT EXPIRED TWO DAYS LATER PER THE FAMILY'S REQUEST TO TERMINATE LIFE SUPPORT. A GTS REPRESENTATIVE INSPECTED THIS PHOENIX MACHINE.