FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 2962800 · Received February 14, 2013

Report

Report Number: 1416980-2013-03884
Event Type: Malfunction
Date Received: February 14, 2013
Date of Event: September 23, 2012
Report Date: February 4, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
Removal / Correction Number: 1423500-01/08/10-001-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION: 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 UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SENT.

Description of Event or Problem · 1

DURING THE EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED DURING THE THERAPY INITIATED ON (B)(6) 2012 AT 17:54:30. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 2211ML, INDICATING THE HOME PATIENT (HP) DRAINED 2211ML 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
64717	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1