SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-27865
Event Type: Injury
Date Received: August 25, 2014
Report Date: July 29, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS MANIFESTED BY "FEELING SICK" (NOT FURTHER SPECIFIED). THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS POOR ASEPTIC TECHNIQUE AND THE PATIENT ¿DIDN¿T CLOSE DOOR¿ (NO FURTHER DETAILS WERE PROVIDED). FIVE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED FOR THE PERITONITIS WITH ANCEF AND FORTAZ (DOSES, FREQUENCIES, AND ROUTES UNKNOWN). FIVE DAYS AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVED, THE PATIENT WAS RECOVERED AND DIANEAL/EXTRANEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
513741		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

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