PHOENIX
Received Nov 21, 2007 · Event occurred Oct 22, 2007
Report 2087532-2007-00221 · MDR key 961590
Device
Generic name
Hemodialysis Equipment
Manufacturer
Gambro DascoModel number
PHOENIXCatalog number
6023006700
Lot number
NA
Product problems
- Normal
Patient
14 YR
- Chest Pain
- Breathing difficulties
Narrative
Description of Event or Problem
GAMBRO RECEIVED A COMPLAINT IN 2007 FROM A FACILITY WHO REPORTED THAT A PT, 2.5 HOURS INTO A FOUR-HOUR TREATMENT, EXPERIENCED WHAT APPEARED TO BE AIR EMBOLI ON A PHOENIX MACHINE. THE PT COMPLAINED OF SHORTNESS OF BREATH (SOB) AND CHEST PAIN (CP) AND WAS GIVEN 2L OF OXYGEN (O2) VIA NASAL CANNULA, PLACED IN THE TRENDELENBERG POSITION AND PUT ON HIS LEFT SIDE PER THE TYPICAL AIR EMBOLI PROTOCOL. THE PT RECOVERED APPROX 1.5 HOURS LATER WITH NO APPARENT INJURY AND WAS DISCHARGED HOME. THE CUSTOMER RAN A PT SIMULATION AFTER THE EVENT AND THE MACHINE PERFORMED ACCORDING TO MFR'S SPECIFICATIONS. THE ULTRASONIC AIR IN BLOOD DETECTOR (UABD) WORKED ACCORDING TO MFR'S SPECIFICATIONS.