SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-12724
Event Type: Injury
Date Received: April 18, 2014
Date of Event: March 24, 2014
Report Date: March 25, 2014
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 CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE AREA WAS NOT CLEANED PRIOR TO PERFORMING PD THERAPY. ON THE SAME DAY AS ONSET, THE PT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH IP (INTRAPERITONEAL) GENTAMICIN, INJ (INJECTION) (21 DAYS, 2 GMS IN EACH BAG) AND IP VANCOMYCIN, INJ (STAT OF 2 GMS AND REPEAT ON 7 DAYS) FOR PERITONITIS. THE PATIENT¿S CONDITION WAS REPORTED AS STABLE AND THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS DISCONTINUED AND THE PT WAS PUT ON HEMODIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237399		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR		Hospitalization\| R	DIANEAL PD2, 1.5% ULTRABAG