SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3864425 · Received June 10, 2014

Report

Report Number: 1416980-2014-18616
Event Type: Death
Date Received: June 10, 2014
Date of Event: May 7, 2014
Report Date: May 16, 2014
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED AND THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY LOSS OF APPETITE AND NAUSEA. ON AN UNREPORTED DATE THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS, DISCHARGED HOME (UNKNOWN DATE) AND THEN READMITTED 9 DAYS PRIOR TO RECEIPT OF THIS REPORT. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (FOR APPROXIMATELY 2 WEEKS). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TWO DAYS AFTER HOSPITALIZATION THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE PERITONITIS. IT WAS REPORTED PD THERAPY WAS WITHDRAWN ONE DAY PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339194		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Death\| H\| R	DIANEAL 1.5% SOLUTION