FDA Adverse Event Injury Summary report: N

RENAL - DISPOSABLE

MDR report key: 1932589 · Received December 18, 2010

Report

Report Number: 1423500-2010-07043
Event Type: Injury
Date Received: December 18, 2010
Date of Event: November 1, 2010
Report Date: November 26, 2010
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY, INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS REPORTED AS UNKNOWN. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH FORTUM 1GM, ONCE DAILY, IP AND REFLIN 1GM ONCE DAILY, IP. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED WITH THE ANTIBIOTIC THERAPY AND THE DIANEAL PD2 ULTRABAG THERAPY ONGOING. THE OUTCOME OF THE EVENT OF PERITONITIS WAS REPORTED AS UNKNOWN. THE NURSE REPORTED THE EVENT OF PERITONITIS WAS NOT RELATED TO THE DIANEAL PD2 ULTRABAG THERAPY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Hospitalization\| R	DIANEAL PD2 ULTRABAG