FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2873105 · Received December 13, 2012

Report

Report Number: 1416980-2012-07326
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: December 9, 2012
Report Date: December 9, 2012
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THIS COMPLAINT IS FOR A REPORT OF A LEAK ISSUE IS NOT CONFIRMED BECAUSE PATIENT REPORTED ABOUT A LEAK FROM THE PATIENT LINE DURING SETUP. ASSIGNABLE CAUSE IS UNDETERMINED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE LEAK.

Description of Event or Problem · 1

A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) FOR SETUP HELP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO GET STARTED ON THE HOMECHOICE (HC) AND GO THROUGH THE BEGINNING, SELF TESTING, AND PRIMING. THE HP THEN STATED THAT THERE WAS A LEAK COMING FROM THE PATIENT LINE. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR			HOMECHOICE