HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2970306 · Received February 20, 2013

Report

Report Number: 1416980-2013-04272
Event Type: Death
Date Received: February 20, 2013
Date of Event: January 10, 2013
Report Date: January 28, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. SINCE A SAMPLE WAS NOT RETURNED FOR EVALUATION, AN EVALUATION COULD NOT BE PERFORMED.

Description of Event or Problem · 1

THIS IS A REPORT OF PATIENT WITH PERITONITIS, FATAL VOLUNTARY WITHDRAWAL OF PERITONEAL DIALYSIS (PD) THERAPY, AND FATAL HEART FAILURE. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS AND HEART FAILURE. THE CAUSE OF THE PERITONITIS WAS UNKNOWN BUT THE PATIENT DID HAVE A PAST MEDICAL HISTORY OF HEART FAILURE. TREATMENT WAS NOT REPORTED. THE PATIENT VOLUNTARILY WITHDREW FROM PD THERAPY PRIOR TO DEATH. THE REPORTED CAUSE OF DEATH WAS HEART FAILURE AND VOLUNTARY WITHDRAWAL OF PD THERAPY. IT WAS UNKNOWN IF THE PATIENT'S CONDITION OF HEART FAILURE HAD WORSENED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. THE NURSE DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT AS THE PATIENT WAS NO LONGER ON PD THERAPY AT THE TIME OF DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
73243	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Death	DIANEAL LOW CALCIUM\| HOMECHOICE