HOMECHOICE

Report

Report Number: 1416980-2014-23221
Event Type: Death
Date Received: July 18, 2014
Date of Event: June 22, 2014
Report Date: June 24, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF THE EVENT HISTORY LOG DID NOT VERIFY THE REPORTED EVENT AND REVEALED THERE WERE NO KEYSTROKES, MALFUNCTION, PROGRAMMING, USE RELATED, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A SAMPLE ANALYSIS WAS NOT ABLE TO PERFORMED ON THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE, PASSED AWAY DUE TO AN UNKNOWN CAUSE. THE PT HAD BEEN RESIDING IN A SKILLED NURSING FACILITY FOR REHABILITATION PRIOR TO DEATH. IN THE SKILLED NURSING FACILITY PD THERAPY WAS ON-GOING. IT WAS REPORTED THAT THE PT WENT BACK AND FORTH BETWEEN USING THEIR HC CYCLER AND MANUAL SUPPLIES BASED ON PREFERENCE. THE PT WAS NOT CONNECTED TO THE CYCLER AT THE TIME OF DEATH AND WAS ON LEAVE AWAY FROM THE NURSING FACILITY AT THE TIME OF THE EVENT. AN AUTOPSY WAS NOT PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421305	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Death	DIANEAL PD4, 2.5% ULTRABAG\| DIANEAL PD4, 4.25% ULTRABAG