MalfunctionFKY
AUTOMATED PD SET W/CASSETTE4 PRONG
Received Nov 10, 2008 · Event occurred Oct 21, 2008
Report 1423500-2008-00900 · MDR key 1243206
Device
Product problems
- Disconnection
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR CODE 2240 THAT OCCURRED ON THE HOME CHOICE (HC) DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED TO START OVER WITH NEW SUPPLIES. THE SPOUSE STATED, THE PATIENT LINE DISCONNECTED WHEN THE PATIENT ROLLED OVER IN BED. THE NURSE WAS CONTACTED AND STATED THERE WERE NO REPOTS OF THE EVENT FROM THE PATIENT OR SPOUSE AND THAT THE PATIENT HAD NO INJURIES RELATED TO THE EVENT. THE HC UNIT WAS OPERATIONAL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.