RENAL - DISPOSABLE

Report

Report Number: 1423500-2010-05632
Event Type: Injury
Date Received: November 11, 2010
Date of Event: October 1, 2010
Report Date: October 21, 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. 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. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF FUNGAL PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH VANCOMYCIN (1.5 GM, LOADING DOSE, IP), MEROPENEM (1 GM, LOADING DOSE, IP) AND BEGAN DAILY REMEDIAL TREATMENT WITH TOBRAMYCIN (40 MG, IP). ON (B)(6) 2010, THE PD THERAPY WAS DISCONTINUED AND THE PD CATHETER WAS REMOVED. ON THE SAME DAY, TOBRAMYCIN THERAPY WAS ALSO DISCONTINUED. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. THE PATIENT REMAINED HOSPITALIZED AT THE TIME OF REPORTING. UPON FOLLOW-UP WITH THE NURSE ON (B)(4) 2010, IT WAS FOUND THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2010.

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	59 YR		Hospitalization\| R	DIANEAL PD2 ULTRABAG