SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1423500-2011-05153
Event Type: Injury
Date Received: April 29, 2011
Date of Event: March 1, 2011
Report Date: April 5, 2011
Manufacturer: BAXTER HEALTHCARE CORPORATION
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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCE PERITONITIS AND WAS HOSPITALIZED THAT DAY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH INJECTION VANCOMYCIN (2GM, FREQUENCY UNKNOWN) AND INJECTION AMIKACIN (100MG IN 1 BAG DAILY). AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING. TREATMENT CONTINUED WITH DIANEAL PD2 ULTRABAG. THE NURSE DID NOT BELIEVE THAT THE PERITONITIS WAS RELATED TO THE DIANEAL PD2 ULTRABAG THERAPY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Hospitalization\| R	DIANEAL PD2 ULTRABAG