FDA Adverse Event Malfunction Summary report: N

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

MDR report key: 3790817 · Received May 5, 2014

Report

Report Number: 1416980-2014-14494
Event Type: Malfunction
Date Received: May 5, 2014
Date of Event: April 12, 2014
Report Date: April 12, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: FKX
PMA / PMN Number: K923065
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AN ISSUE INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT 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 AUTOMATED PD SET WITH CASSETTE HAD A LOOSE CONNECTION WITH AN UNKNOWN BAG. THIS WAS NOTICED BY THE CARE GIVER (CG) DURING SETUP, BEFORE THE HOME PATIENT (HP) CONNECTED. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS ISSUE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO RESTART SETUP USING 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
267689	HOMECHOICE AUTOMATED PD SET WITH CASSETTE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - MOUNTAIN HOME

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR			HOMECHOICE