RENAL - DISPOSABLE

Report

Report Number: 1423500-2010-02568
Event Type: Injury
Date Received: August 17, 2010
Date of Event: July 27, 2010
Report Date: August 12, 2010
Manufacturer: UNKNOWN MANUFACTURING FACILITY
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PATIENTS DISCARD THE SAMPLES AFTER EACH THERAPY, THEREFORE NO SAMPLE WAS RETURNED FOR EVALUATION. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(4) OF PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 ULTRABAG INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY, A PERITONEAL EFFLUENT ANALYSIS AND CULTURE WERE PERFORMED. THE ANALYSIS REVEALED 920 CELLS/MM3 LEUKOCYTES WITH 60% NEUTROPHILS AND 40% LYMPHOCYTES. THE RESULTS OF THE CULTURE WERE UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM (1GM, DAILY, IP) AND REFLIN (1GM, LOADING DOSE, IP). DIANEAL THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH FORTUM. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention	DIANEAL PD2 ULTRABAG THERAPY. IN (B)(6)2010, THE P