SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-18980
Event Type: Injury
Date Received: June 13, 2014
Report Date: May 20, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: HK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). IT WAS REPORTED THAT THE PATIENT'S PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, AND FEVER. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. IT WAS REPORTED THAT THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THERE WAS NO FURTHER DESCRIPTION OF THE BREAK IN ASEPTIC TECHNIQUE. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

(B)(4): ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. IT WAS UNKNOWN IF PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351339		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1				DIANEAL