SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1423500-2011-06497
Event Type: Injury
Date Received: May 25, 2011
Date of Event: January 1, 2011
Report Date: May 6, 2011
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ROOT CAUSE IS UNDETERMINED. THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2008, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (3L, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED WHETHER A PERITONEAL EFFLUENT CULTURE OR ANALYSIS WERE PERFORMED OR WHETHER TREATMENT WAS RENDERED. IT WAS NOT REPORTED IF THE EVENT OF PERITONITIS RESOLVED OR IF DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	DIANEAL PD2 ULTRABAG