SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1416980-2014-16833
Event Type: Injury
Date Received: May 23, 2014
Date of Event: April 16, 2014
Report Date: April 28, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VM
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE CAUSE OF THE PERITONITIS WAS REPORTED TO BE DUE TO ¿POOR ENVIRONMENT IN FLUID CHANGING ROOM¿ FURTHER DESCRIBED AS DIRTY AND DUSTY (NO FURTHER DETAILS PROVIDED). THE PT WAS HOSPITALIZED THE SAME DAY AS ONSET. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH CEFAZOLIN AND FORTAM (1 G, FREQUENCY NOT REPORTED) IP (INTRAPERITONEALLY) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN HOSPITAL. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PT WAS RECOVERING, AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308383		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Hospitalization\| R	DIANEAL 2.5% PD4\| DIANEAL 1.5% PD4