FDA Adverse Event Injury Summary report: N

MINICAP

MDR report key: 3899902 · Received June 27, 2014

Report

Report Number: 1416980-2014-20605
Event Type: Injury
Date Received: June 27, 2014
Date of Event: May 29, 2014
Report Date: June 3, 2014
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER OF D896589 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT EXPERIENCED FUNGAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR AN UNRELATED EVENT FOR A ONE DAY HOSPITAL STAY. FIVE DAYS AFTER THE INITIAL HOSPITAL STAY AND DISCHARGE; THE PATIENT WAS READMITTED. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. STATUS OF THE HOSPITALIZATION WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS RECOVERING OR HAD RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE DISCONTINUED, THE PERITONEAL DIALYSIS CATHETER WAS REMOVED, AND THE PATIENT WAS STARTED ON HEMODIALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
377106	MINICAP	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	TRANSFER SET, CASSETTE\| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX, FLEXICAP