FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 4781915 · Received May 19, 2015

Report

Report Number: 1416980-2015-22022
Event Type: Malfunction
Date Received: May 19, 2015
Date of Event: May 2, 2015
Report Date: May 2, 2015
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). IMPROPER DISCONNECT/RECONNECT IS A KNOWN CAUSE OF THIS ALARM. 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 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 HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN ONE OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PATIENT IMPROPERLY DISCONNECTED AND RECONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE PATIENT WITH ENDING THERAPY AND REVIEWED PROPER PROCEDURES AS PER USER MANUAL. 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
326335		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOMECHOICE