FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3760998 · Received April 21, 2014

Report

Report Number: 1416980-2014-12772
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: January 31, 2014
Report Date: March 27, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS EVALUATED AND THE EVENT WAS CONFIRMED THROUGH THE REVIEW OF THE EVENT HISTORY LOG. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE A USE ERROR, INSUFFICIENT DRAIN DUE TO THE TIDAL TOTAL ULTRAFILTRATION (UF) REMOVAL BEING SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. THE GUIDE WARNS THAT "A TOTAL UF VOLUME SET TOO LOW CAN RESULT IN A GRADUAL BUILDUP OF UF VOLUME DURING THE THERAPY." THIS CAN RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THERAPY INITIATED ON (B)(6) 2014 AT 20:00:13. DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 1651ML, INDICATING THE HOME PATIENT (HP) DRAINED 1561ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 1800ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
240551	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1