FDA Adverse Event Malfunction Summary report: N

HOMECHOICE, DOMESTIC 120V

MDR report key: 3102758 · Received May 9, 2013

Report

Report Number: 1416980-2013-11818
Event Type: Malfunction
Date Received: May 9, 2013
Date of Event: April 7, 2013
Report Date: April 18, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

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 OPENED DURING INVESTIGATION OF (B)(4). (SAME DEVICE, PATIENT AS IN RELATED (B)(4).)THE REPORTED DIFFICULTY OF AN IIPV EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS USE ERROR, TIDAL TOTAL UF REMOVAL SET TOO LOW. HOMECHOICE APD SYSTEMS TRAINER'S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2013 21:23:26. DURING NIGHT DRAIN CYCLE FIVE, THE PATIENT'S ULTRAFILTRATION READING WAS 2887ML, INDICATING THE HOME PATIENT (HP) DRAINED 2787ML 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
203834	HOMECHOICE, DOMESTIC 120V	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1