HOMECHOICE CYCLER-REFURBISHED

MDR report key: 1071506 · Received July 2, 2008

Report

Report Number: 1423500-2008-00586
Event Type: Malfunction
Date Received: July 2, 2008
Date of Event: June 13, 2008
Report Date: June 13, 2008
Manufacturer: BAXTER HEALTHCARE
Product Code: FKX
PMA / PMN Number: K012988
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B) (4): CUSTOMER SAMPLE RECEIVED; HOWEVER, EVALUATION NOT YET COMPLETED.

Description of Event or Problem · 1

THE HOME PATIENT (HP) CONTACTED A TECHNICAL SERVICE REPRESENTATIVE (TSR) AND REPORTED ABDOMINAL DISTENTION, AS IF SHE WERE OVERFILLED WITH FLUID, DURING DWELL 1 USING THE HOMECHOICE AUTOMATED PERITONEAL DIALYSIS (APD) SYSTEM. THE INCIDENT WAS REVIEWED OVER THE PHONE WITH THE TSR, WHO VERBALLY ASSISTED THE HP TO PERFORM A MANUAL DRAIN. THE HP REMOVED 2698MLS OF FLUID, WHICH WAS 698MLS GREATER THAN THE LAST FILL VOLUME RECEIVED OF 2000MLS. THE INITIAL DRAIN VOLUME WAS 227MLS. THE CYCLER WAS PROGRAMMED FOR TOTAL VOLUME = 11500MLS, THERAPY TIME = 10 HRS, FILL VOLUME = 2000MLS , LAST FILL = 0MLS, DEXTROSE = SAME , INITIAL DRAIN ALARM SETPOINT= 0MLS, LAST MANUAL DRAIN= NO. THE HP WAS USING 2.5% DEXTROSE CONCENTRATION SOLUTION DURING THE THERAPY. THE TSR SUBSEQUENTLY SWAPPED THE CUSTOMER'S DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORTED INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE CYCLER-REFURBISHED	78FKX	FKX	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1				5B9771 2.5% LO/CAL6L DIANEAL