SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1423500-2011-05034
Event Type: Injury
Date Received: April 26, 2011
Date of Event: February 1, 2011
Report Date: April 6, 2011
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REGULATORY REPORT FROM (B)(4) BY THE (B)(4) OF ASEPTIC PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY PERITONEAL DIALYSIS (PD). THIS REPORT WAS RECEIVED BY THE (B)(4) AND FORWARDED TO BAXTER (B)(4). ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR ASEPTIC PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT'S CLINICAL EXAMINATION WAS REPORTED AS NORMAL, AND CREATININE REACTIVE PROTEIN (CRP) WAS REPORTED AS INCREASED. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED TREATMENT. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT OF ASEPTIC PERITONITIS. ACTION TAKEN WITH EXTRANEAL VIAFLEX THERAPY WAS NOT REPORTED. THE (B)(4) REPORTED THE CAUSALITY ASSESSMENT FOR THE EVENT OF ASEPTIC PERITONITIS AS UNLIKELY ASSOCIATED WITH EXTRANEAL VIAFLEX THERAPY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Hospitalization	EXTRANEAL VIAFLEX