RENAL - DISPOSABLE

Report

Report Number: 1423500-2010-05027
Event Type: Injury
Date Received: October 28, 2010
Date of Event: October 1, 2010
Report Date: October 7, 2010
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VM
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 PATIENT DISCARDED 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

Description of Event or Problem · 1

ON(B)(6)2007, THE PATIENT STARTED PERITONEAL DIALYSIS (PD) TREATMENT. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POOR ENVIRONMENT. ON (B)(6)2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL PAIN AND FEVER. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON THE SAME DAY, A PERITONEAL ANALYSIS AND CULTURE WERE PERFORMED. THE RESULTS OF THE CULTURE WERE NO GROWTH. ON AN UNKNOWN DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAZOLIN (1GM X 2GM, DAILY) AND GENTAMYCIN (40MG X 80MG, DAILY). THE RESULTS OF THE PERITONEAL EFFLUENT CULTURE OF (B)(6)2010 WERE NO GROWTH. PD THERAPY WAS ONGOING. THE PERITONITIS AND FEVER WERE ONGOING AND IMPROVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2010. ON AN UNSPECIFIED DATE IN 2010, THE PATIENT RECOVERED FROM THE EVENTS OF FEVER AND PERITONITIS. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE REPORTER BELIEVED THAT THE EVENTS OF PERITONITIS WAS UNRELATED TO PD THERAPY. NO CAUSALITY STATEMENT WAS PROVIDED FOR THE EVENT OF FEVER.

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				DIANEAL PD4 ULTRABAG