FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 2972255 · Received February 21, 2013

Report

Report Number: 1416980-2013-04328
Event Type: Injury
Date Received: February 21, 2013
Date of Event: January 21, 2013
Report Date: January 29, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) AND AMBULATORY PERITONEAL DIALYSIS (APD). THE PATIENT EXPERIENCED A COLD AND, LATER, PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THE COLD. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT WAS NOT REPORTED. ACTION TAKEN WITH THE CAPD AND APD THERAPIES WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE COLD. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF PERITONITIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77126		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	DIANEAL PD2 1.5%, DIANEAL PD2 2.5%, EXTRANEAL 7.5%