FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 2992440 · Received March 7, 2013

Report

Report Number: 1416980-2013-05478
Event Type: Malfunction
Date Received: March 7, 2013
Date of Event: July 16, 2012
Report Date: February 17, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Removal / Correction Number: 1423500-01/08/10-001-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT. THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM DURING INITIAL DRAIN. HOMECHOICE / HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE PROVIDES INSTRUCTIONS ON HOW TO BYPASS LDV ALARM IN INITIAL DRAIN ON PAGES 15-65. THE LABELING ALSO STATES, "BY SELECTING BYPASS, YOU INDICATE THAT YOU ARE EMPTY. THE SYSTEM CONSIDERS YOUR VOLUME ZERO (0) AND DELIVERS YOUR ENTIRE PRESCRIBED FILL VOLUME." IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED AS HAVING OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2012 20:26:51. DURING NIGHT DRAIN CYCLE ONE, THE PATIENT'S ULTRAFILTRATION READING WAS 1639ML, INDICATING THE HOME PATIENT (HP) DRAINED 1639ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2000ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
98069	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1