inforMED
InjuryFII

PHOENIX

Received Nov 21, 2007 · Event occurred Oct 22, 2007

Report 2087532-2007-00221 · MDR key 961590

Device

Generic name

Hemodialysis Equipment

Manufacturer

Gambro Dasco

Model number

PHOENIX

Catalog 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.