FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 4854120 · Received June 18, 2015

Report

Report Number: 1416980-2015-25773
Event Type: Malfunction
Date Received: June 18, 2015
Date of Event: June 9, 2015
Report Date: June 9, 2015
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS A REPORT OF A USE ERROR, WHERE THE PATIENT WAS CONNECTED TO THERAPY BEFORE PRIMING OF THE DISPOSABLE SET. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE¿, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. 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 PATIENT CONNECTED TO THERAPY BEFORE PRIMING OF THE DISPOSABLE SET. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THIS OCCURRED DURING PRIMING OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WANTED TO KNOW WHEN THEY SHOULD DISCONNECT THEMSELVES AFTER THE PRIME WAS COMPLETED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE PATIENT THAT THEY SHOULD NOT HAVE BEEN CONNECTED DURING THE PRIME CYCLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
396864		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR			HOMECHOICE