SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

MDR report key: 3873552 · Received June 14, 2014

Report

Report Number: 1416980-2014-19062
Event Type: Injury
Date Received: June 14, 2014
Date of Event: May 25, 2014
Report Date: May 25, 2014
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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY SOLUTION (PERITONEAL DIALYSIS EFFLUENT). AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH UNSPECIFIED MEDICATION (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. THE OUTCOME OF THE PERITONITIS WAS NOT REPORTED. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
351722		SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	DIANEAL 2.5%\| DIANEAL 1.5% PD2 ULTRABAG