HOMECHOICE AUTOMATED PD SET WITH CASSETTE

Report

Report Number: 1416980-2014-16795
Event Type: Injury
Date Received: May 23, 2014
Date of Event: April 7, 2014
Report Date: April 29, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13L15066 AND H14A03071 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS NOT RESPONDING TO OUTPATIENT TREATMENT FOR PERITONITIS. THREE WEEKS AFTER THE ONSET, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE PT REMAINED HOSPITALIZED AND HAD NOT RECOVERED. ON AN UNREPORTED DATE, PD THERAPY WAS DISCONTINUED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
307353	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Hospitalization\| R	MINICAP TRANSFER SET\| HOMECHOICE\| DIANEAL PD2 1.5% AMBUFLEX\| MINICAP