SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2015-26204
Event Type: Injury
Date Received: June 23, 2015
Date of Event: June 1, 2015
Report Date: June 1, 2015
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE AND DID NOT WEAR A MASK. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH VANCOMYCIN 1 GRAM ONCE IN FOUR DAYS INTRAPERITONEALLY (DURATION NOT REPORTED) AND MEROPENEM 1 GRAM ONCE DAILY (ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. IT WAS NOT REPORTED IF DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE, THE PERITONEAL EFFLUENT FLUID WAS CLEAR AND THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
406539		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention	DIANEAL 2.5% ULTRABAG