FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 2896258 · Received January 4, 2013

Report

Report Number: 1416980-2013-00257
Event Type: Malfunction
Date Received: January 4, 2013
Date of Event: December 14, 2012
Report Date: December 14, 2012
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE SYSTEM ERROR 2240 (AIR IN LINE) IS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NEITHER THE DISPOSABLE SET NOR THE HOMECHOICE MACHINE WERE RETURNED FOR EVALUATION. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. PER THE CAREGIVER (CG) THERE WAS MORE MOISTURE UNDER THE EMPTY BAG BUT THE USER DID NOT VERBALLY PROVIDE SUFFICIENT INFORMATION TO IDENTIFY THE CAUSE OF THE ALARM.

Additional Manufacturer Narrative · 1

(B)(4). THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING DWELL 3 OF 5 THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AND PER THE CAREGIVER (CG) THERE WAS MORE MOISTURE UNDER THE EMPTY BAG. THEY CYCLED THE POWER AND THE SYSTEM ERRORED 2367 AND THE TSR ASSISTED TO RETRIEVE THE CASSETTE AND ADVISED TO LET THE REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
4826	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR			HOMECHOICE