COMPACT EXCHANGE DEVICE

Report

Report Number: 1423500-2011-09902
Event Type: Injury
Date Received: July 28, 2011
Date of Event: January 1, 2011
Report Date: July 7, 2011
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: KDJ
PMA / PMN Number: K851208
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

Additional Manufacturer Narrative · 1

(B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

Description of Event or Problem · 1

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR FUNGAL IN A PATIENT COINCIDENT WITH DIANEAL UNKNOWN, DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. ON AN UNREPORTED DATE, DIANEAL UNKNOWN, DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES HAD BEEN WITHDRAWN. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR FUNGAL WAS UNRELATED TO DIANEAL THERAPIES.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Other	DIANEAL PD4 ULTRABAG\| DIANEAL PD4 AMBUFLEX\| HOMECHOICE\| DIANEAL