FDA Adverse Event Injury Summary report: N

DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

MDR report key: 4251652 · Received November 14, 2014

Report

Report Number: 1416980-2014-40649
Event Type: Injury
Date Received: November 14, 2014
Report Date: October 22, 2014
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PATIENT DEVELOPED PERITONITIS ON AN UNSPECIFIED DATE IN (B)(6) 2014. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. 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. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS TREATED WITH VANCOMYCIN INTRAPERITONEALLY (IP) (500MG DAILY) AND FORTAZ (CEFTAZIDIME) IP (1G DAILY) FOR THE EVENT. AT THE TIME OF THIS REPORT, ANTIBIOTIC TREATMENT WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE EVENT. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 4 OF 4 INVOLVED IN THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
738543		DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	DIANEAL ULTRABAG, DIANEAL AMBUFLEX, CASSETTE\| TITANIUM ADAPTER, TRANSFER SET, HOMECHOICE