SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2013-05367
Event Type: Injury
Date Received: March 6, 2013
Date of Event: February 12, 2013
Report Date: February 13, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: RP
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS REPORT OF PERITONITIS CAUSED BY USE ERROR-BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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 ROOT CAUSE OF THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS, WHICH CAUSED PERITONITIS. THE HP WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE HP WAS TREATED WITH CEFEPIME 500MG (FREQUENCY AND ROUTE NOT REPORTED) FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THE HP WAS RETRAINED ON PROPER ASEPTIC PROCEDURES. THE OUTCOME OF THE PERITONITIS EVENT IS UNKNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
94945		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR		Required Intervention	DIANEAL PD2 2.5%, AMLODIPINE, LANOXIN\| CALCIUM CARBONATE, FERROUS SULPHATE, CARVEDILOL