FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3812081 · Received May 15, 2014

Report

Report Number: 1416980-2014-15482
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 19, 2014
Report Date: April 19, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2367 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING DWELL THREE OF FOUR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SYSTEM ERROR 2367 TO CAREGIVER (CG). THE CG STATED THAT THERE WAS MOISTURE ON THE BAG. THE TSR ADVISED CG THAT THE HP MUST EITHER START OVER WITH ALL NEW SUPPLIES ON THE HC OR USE MANUAL SUPPLIES TO COMPLETE THERAPY. THE CG WOULD HAVE HP USE MANUAL SUPPLIES TO COMPLETE THERAPY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290199	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR			HOMECHOICE