SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-18256
Event Type: Injury
Date Received: June 6, 2014
Date of Event: May 14, 2014
Report Date: May 14, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): IT WAS REPORTED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERED FROM THIS PERITONITIS EVENT ON (B)(6) 2014.SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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 MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD FLUIDS. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE PERITONITIS EVENT AND BEGAN TREATMENT WITH CEFAZOLIN (2G/DAY, IP) AND GENTAMYCIN (80MG/DAY, IP). EIGHT DAYS LATER, TREATMENT WITH CEFAZOLIN AND GENTAMYCIN WAS STOPPED. ON AN UNREPORTED DATE, THE PT WAS RETRAINED ON ASEPTIC TECHNIQUE. AT THE TIME OF THIS REPORT, THE PT WAS NOT RECOVERED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
332646		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	DIANEAL PD4 1.5% AND 2.5%