FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3871377 · Received June 13, 2014

Report

Report Number: 1416980-2014-18851
Event Type: Malfunction
Date Received: June 13, 2014
Date of Event: May 17, 2014
Report Date: May 17, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PATIENT DISCONNECTING INCORRECTLY FROM THE SETUP IS A KNOWN CAUSE OF THIS ALARM. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES. ALSO, IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED DURING DRAIN ONE OF SIX ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) HAD DISCONNECTED IMPROPERLY FROM THE SETUP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO END THERAPY AND RESTART THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350278	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR			HOMECHOICE