FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 2964063 · Received February 15, 2013

Report

Report Number: 1416980-2013-03965
Event Type: Injury
Date Received: February 15, 2013
Date of Event: December 12, 2012
Report Date: January 24, 2013
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF PERITONITIS WAS CONFIRMED TO BE CAUSED BY A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS MADE A MISTAKE AND TOUCH CONTAMINATION. A SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS MADE A MISTAKE AND TOUCH CONTAMINATION, WHICH CAUSED PERITONITIS DURING PERITONEAL DIALYSIS (PD) THERAPY USING UNKNOWN BAXTER DISPOSABLES. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT INCLUDED VANCOMYCIN INTRAPERITONEALLY (IP) FOR THREE WEEKS. RETRAINING ON PROPER ASEPTIC TECHNIQUE WAS PERFORMED. THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
66209		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Required Intervention	HOMECHOICE\| DIANEAL LOW CALCIUM ULTRABAG\| DIANEAL LOW CALCIUM AMBUFLEX