FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3851493 · Received June 5, 2014

Report

Report Number: 1416980-2014-17999
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: May 4, 2014
Report Date: May 12, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. REVIEW OF THE EVENT LOG FOUND EVIDENCE OF THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV) CONDITION. ALL RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. A VISUAL INSPECTION WAS PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. THE CAUSE WAS DETERMINED TO BE A USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL WAS SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A FORMAL 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

DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2014, AT 19:43:51. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1746ML, INDICATING THE HOME PATIENT (HP) DRAINED 1631ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2300ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329278	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR