SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Report

Report Number: 1423500-2012-15762
Event Type: Injury
Date Received: August 8, 2012
Date of Event: July 1, 2012
Report Date: July 21, 2012
Manufacturer: BAXTER HEALTHCARE
Product Code: KDJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE COMPLAINT WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE (B)(6) OF PERITONEAL CLOUDY EFFLUENT IN A PATIENT COINCIDENT WITH DIANEAL-N PD-4 (DIANEAL-N PD-4 1.5 PD SOLUTION) AND EXTRANEAL THERAPIES. ON (B)(6) 2012, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED TO DIAGNOSE WITH PERITONEAL CLOUDY EFFLUENT. THE PATIENT HAS NO ABNORMALITIES OR SIGNS OF PERITONITIS. THE PATIENT'S PERITONEAL EFFLUENT WAS OFTEN CLOUDY WITH NO ABNORMALITIES. TREATMENT WAS NOT REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	DIANEAL-N PD-4