FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3930928 · Received July 13, 2014

Report

Report Number: 1416980-2014-22479
Event Type: Injury
Date Received: July 13, 2014
Date of Event: May 30, 2014
Report Date: June 17, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS A REPORT OF A USE ERROR THAT RESULTED IN PERITONITIS. 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. 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 A BREACH IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFTAZIDIME(1GRAM DAILY FOR 3 WEEKS, ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO WEEKS AFTER BEING ADMITTED. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WOULD BE RETRAINED OR IF THE PATIENT HAD BEEN RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
408997		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Hospitalization\| R	DIANEAL 2.5% LOW CALCIUM ULTRABAG