FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3873530 · Received June 14, 2014

Report

Report Number: 1416980-2014-19061
Event Type: Injury
Date Received: June 14, 2014
Report Date: May 25, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CAUSE OF THE PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS PATIENT MADE A MISTAKE BY CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) BEING PERFORMED WITHOUT PROPER TRAINING. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH VANCOGEN INJECTION 1GM INTRAPERITONEALLY (FREQUENCY AND DURATION NOT REPORTED), FOR THE PERITONITIS EVENT. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS EVENT AND DIANEAL THERAPY WAS ONGOING. IT WAS UNKNOWN IF THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351853		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Hospitalization\| R	CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD)\| DIANEAL 2.5% PD2 ULTRABAG