RENAL - DISPOSABLE

Report

Report Number: 1423500-2010-05997
Event Type: Injury
Date Received: November 22, 2010
Date of Event: October 1, 2010
Report Date: October 27, 2010
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: NURSE

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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF CHEMICAL PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEMICAL PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND BLURRY PERITONEAL EFFLUENT. NO REMEDIAL TREATMENT WAS GIVEN TO THE PATIENT. PER THE REPORTER, THE BLURRY PERITONEAL EFFLUENT HAD BEEN CONFIRMED AND THE SOLUTION HAD BEEN CHANGED. ON (B)(6) 2010, EXTRANEAL THERAPY WITH LOT# M1008015 WAS DISCONTINUED. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT RECOVERED FROM THE EVENT OF CHEMICAL PERITONITIS. IT WAS UNKNOWN WHETHER THE PATIENT CONTINUED THERAPY WITH A DIFFERENT LOT OF EXTRANEAL. THE REPORTER BELIEVED THE EVENT OF CHEMICAL PERITONITIS WAS RELATED TO EXTRANEAL THERAPY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Other	EXTRANEAL VIAFLEX, ORAL CARDURA (ALFA 1-BLOCKER)\| ORAL BEMIKS (VITAMIN B COMBINATION)\| INTRAVENOUS MIRCERA (M.P.G. - EPOETIN BETA)