FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 4810465 · Received June 2, 2015

Report

Report Number: 1416980-2015-23599
Event Type: Malfunction
Date Received: June 2, 2015
Date of Event: May 18, 2015
Report Date: May 18, 2015
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS IS A REPORT OF A USE ERROR, WHERE THE PATIENT CONNECTED TO THE PATIENT LINE WHICH WAS NOT PROPERLY PRIMED. 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 EXPERIENCED A USE ERROR DURING INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE DEVICE. THE PATIENT CONNECTED TO THE PATIENT LINE WHICH WAS NOT PROPERLY PRIMED AND INITIATED THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH ENDING THERAPY AND ADVISED TO RESTART THERAPY USING ALL NEW SUPPLIES. 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
356390		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR			HOMECHOICE