PRISMA CONTROL UNIT
Received Feb 1, 2007 · Event occurred Jan 3, 2007
Report 9616240-2007-00015 · MDR key 818965
Device
Generic name
Intensive Care Hemodialysis
Manufacturer
Gambro DascoModel number
PRISMACatalog number
018080001D
Lot number
NA
Product problems
- Air Leak
- Device Alarm System
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THEY HAD AN INCIDENT WHERE THE SET WAS FULL OF AIR AND THE MACHINE DID NOT ALARM.
Additional Manufacturer Narrative
THE PT EXPERIENCED A BLOOD LOSS OF ABOUT 107 ML. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THIS INCIDENT. GAMBRO TECHNICIAN INSPECTED THE MACHINE AND WAS ABLE TO RETRIEVE THE EVENTS HISTORY. IT SHOWED MULTIPLE ALARMS RELATED TO THE PRESENCE OF A CLOT OCCURRING BETWEEN THE ACCESS PRESSURE POD AND THE BLOOD PUMP. THIS USUALLY RESULTS IN THE REPLACEMENT FLUID ENTERING THE SET AND GRADUALLY CLEARING BLOOD FROM THE LINES. THIS CLEAR FLUID COULD BE MISTAKEN FOR AIR IN THE CIRCUIT. A SIMULATED TREATMENT WAS PERFORMED AND THE AIR DETECTOR TESTED AND FOUND TO BE WORKING WITHIN MFR'S SPECIFICATIONS. THE MACHINE HAS BEEN RETURNED TO THE UNIT.