SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-23424
Event Type: Injury
Date Received: July 21, 2014
Date of Event: May 29, 2014
Report Date: June 25, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VM
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN 1956. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS THERAPY, RESULTING IN THE DEVELOPMENT OF PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT TOUCHED THE TIP OF THEIR TRANSFER SET WHEN CHANGING FLUIDS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT WITH SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFAZOLIN (1G FOR 14 DAYS, FREQUENCY NOT REPORTED) AND IP FORTUM (1G FOR 14 DAYS, FREQUENCY NOT REPORTED) FOR THE EVENT. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
424622		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	DIANEAL PD4 1.5%, DIANEAL PD4 2.5%