FDA Adverse Event Malfunction Summary report: N

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

MDR report key: 4863550 · Received June 23, 2015

Report

Report Number: 1416980-2015-26384
Event Type: Malfunction
Date Received: June 23, 2015
Date of Event: June 15, 2015
Report Date: June 15, 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). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 INITIAL DRAIN OF PERITONEAL DIALYSIS THERAPY. THERE WAS NOTHING UNUSUAL FOUND DURING TROUBLESHOOTING THAT WOULD CAUSE OR CONTRIBUTE TO THE ALARM. THE ALARM WAS RESOLVED BY CYCLING POWER ON THE HOMECHOICE DEVICE. THE PATIENT STATED THEY WOULD COMPLETE THERAPY BY STARTING OVER WITH 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
405119		SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR			HOMECHOICE