GAMBRO PHOENIX
Received Oct 28, 2009 · Event occurred Oct 27, 2009
Report 1521658 · MDR key 1521658
Device
Generic name
Hemodialysis Machine
Manufacturer
Gambro Renal Products, Inc.Model number
*Catalog number
*
Lot number
*
Product problems
- Device Alarm System
- Device Operates Differently Than Expected
Patient
54 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PATIENT GETTING HEMODIALYSIS ON RECENTLY PURCHASED GAMBRO PHOENIX DIALYZER. THE MACHINE (1)FAILED TO DETECT AIR IN THE LINE (LIGHT SENSOR SHOULD HAVE PICKED UP MICROFOAM IN LINE), AND, (2) THE AUTOMATIC CLAMPING DEVICE DID NOT CLAMP THE RETURN (VENOUS) LINE. AFTER THE AIR IN THE LINE MIGRATED PAST BOTH THE LIGHT SENSOR AND CLAMP IT DID ALARM, ALERTING RN TO CLAMP OFF LINE WITH NO HARM TO PATIENT.
Description of Event or Problem
PATIENT GETTING HEMODIALYSIS ON RECENTLY PURCHASED GAMBRO PHOENIX DIALYZER. THE MACHINE (1)FAILED TO DETECT AIR IN THE LINE (LIGHT SENSOR SHOULD HAVE PICKED UP MICROFOAM IN LINE), AND, (2) THE AUTOMATIC CLAMPING DEVICE DID NOT CLAMP THE RETURN (VENOUS) LINE. AFTER THE AIR IN THE LINE MIGRATED PAST BOTH THE LIGHT SENSOR AND CLAMP IT DID ALARM, ALERTING RN TO CLAMP OFF LINE WITH NO HARM TO PATIENT.