FDA Adverse Event Malfunction Summary report: N

PD CYCLER 115V, HOMECHOICE

MDR report key: 4090266 · Received September 15, 2014

Report

Report Number: 1416980-2014-31320
Event Type: Malfunction
Date Received: September 15, 2014
Date of Event: August 8, 2014
Report Date: August 21, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED AND EVALUATED FOR THE REPORTED EVENT. A REVIEW OF THE EVENT HISTORY LOG VERIFIED THE OCCURRENCE OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE USER ERROR, TIDAL TOTAL ULTRAFILTRATION (UF) REMOVAL BEING SET TOO LOW. 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 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 IN THE THERAPY INITIATED ON (B)(6) 2014 01:20:49. DURING NIGHT DRAIN CYCLE FOUR, THE PATIENT'S ULTRAFILTRATION READING WAS 1697ML, INDICATING THE HOME PATIENT (HP) DRAINED 1477ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
568701	PD CYCLER 115V, HOMECHOICE	HOMECHOICE	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR