FDA Adverse Event Injury Summary report: N

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3251169 · Received July 29, 2013

Report

Report Number: 1416980-2013-19980
Event Type: Injury
Date Received: July 29, 2013
Date of Event: July 3, 2013
Report Date: July 3, 2013
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). 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, FURTHER DESCRIBED AS DID NOT WEAR A MASK, WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION FORTUM, 500 MG (FREQUENCY AND ROUTE NOT REPORTED), INJECTION REFLIN, 500 MG, IP (FREQUENCY NOT REPORTED), TABLET FLUCON, 150 MG, ORALLY (FREQUENCY NOT REPORTED), AND TABLET, CIFRAN, 250 MG, ORALLY (FREQUENCY NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED, AND THE OUTCOME WAS UNKNOWN. DIANEAL/EXTRANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353564		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Hospitalization\| R	DIANEAL PD2, 1.5% ULTRABAG\| EXTRANEAL VIAFLEX