FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3120327 · Received May 20, 2013

Report

Report Number: 1416980-2013-12903
Event Type: Malfunction
Date Received: May 20, 2013
Date of Event: May 6, 2013
Report Date: May 6, 2013
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE USE ERROR FOR THE INCOMPLETE CONNECTION. THE HOMECHOICE PATIENT AT HOME GUIDE STATES WHEN ATTACHING SOLUTION BAGS TO, "MAKE SURE THE SOLUTION BAGS ARE CONNECTED TO THE PROPER LINES ON THE ORGANIZER," AND ALSO, ?CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING YOUR THERAPY.? SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE PERFORMING PERITONEAL DIALYSIS, A HOME PATIENT (HP) NOTICED A LOOSE CONNECTION BETWEEN THE INTEGRATED SET AND THE HEATER BAG WHILE USING A HOMECHOICE (HC) MACHINE DURING DWELL ONE OF FOUR. THE HP SAW THE CONNECTION COME APART AND CLOSED OFF THE PATIENT LINE AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
222279	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR			HOMECHOICE