MAUDE MDR 1243206

MDR report key: 1243206
Report number: 1423500-2008-00900
Event key: 0
Event type: 3
Date of event: 2008-10-21
Date received: 2008-11-10
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: KAREN KIRBY
Address: 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
Phone: 847-847-8472
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	AUTOMATED PD SET W/CASSETTE4 PRONG	78FKY	BAXTER HEALTHCARE - MOUNTAIN HOME	FKY		5C4469C					R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2008-11-10	0

Event Narratives#

D

Patient 1

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.

N