PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

Report

Report Number: 1423500-2010-04227
Event Type: Death
Date Received: October 8, 2010
Date of Event: July 5, 2009
Report Date: June 30, 2010
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K053512
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). UPON FURTHER INVERTICATION DEVICE EVALUATION REVEALED DOOR ISSUE THAT WOULD NOT LEAD TO HARM IF IT WERE TO RECUR. THE DEVICE LOG REVEALED THAT THE DOOR ALARM DID NOT OCCUR DURING PATIENT USE. THE DEVICE EVALUATION DEMONSTRATED THAT THERE WERE NO IIPV EVENTS AND NO OTHER ALARMS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS PATIENT DEATH. THIS IS NOT A MDR REPORTABLE DEATH.

Additional Manufacturer Narrative · 1

(B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION.

Description of Event or Problem · 1

THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) MACHINE AND RETURNED IT TO BAXTER (B)(4). THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HC MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO AN INITIALIZATION ERROR. ON 09/14/10 PRODUCT SURVEILLANCE CONTACTED THE NURSE WHO STATED THAT THE PATIENT EXPIRED ON (B)(6)2009 AND THAT THERE WAS NO AUTOPSY REPORT. WHEN ASKED IF THE PATIENT HAD ANY ISSUES RELATED TO THE HC DEVICE AND THE PERITONEAL DIALYSIS (PD) THERAPY, THE NURSE STATED THAT THE PATIENT DID NOT HAVE ISSUES PRIOR TO THE DEATH.THE NURSE DID NOT HAVE FURTHER INFORMATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Death