FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 3853688 · Received June 6, 2014

Report

Report Number: 1416980-2014-18160
Event Type: Malfunction
Date Received: June 6, 2014
Date of Event: May 12, 2014
Report Date: May 12, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CLAMP ON THE PATIENT LINE NOT BEING OPENED BEFORE THE PATIENT WAS CONNECTED 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 INFORMS THE USER TO OPEN CLAMPS ON LINES CONNECTED TO SOLUTION BAGS AND THE PATIENT LINE TO ENSURE PROPER PRIMING. IT INSTRUCTS THE USER TO CHECK THE LINES FOR CLOSED CLAMPS. 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 INITIAL DRAIN ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, THE CAREGIVER (CG) STATED THAT THE HOME PATIENT WAS CONNECTED WHILE THE PATIENT LINE CLAMP WAS CLOSED FOR PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE CG AND ASSISTED THE CG IN ENDING THERAPY. THE CG PLANNED TO RESTART THERAPY USING ALL 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
332983		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR			HOMECHOICE