FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3032967 · Received April 3, 2013

Report

Report Number: 1416980-2013-07361
Event Type: Malfunction
Date Received: April 3, 2013
Date of Event: January 8, 2013
Report Date: March 5, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). 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 DETERMINED TO BE FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME PERCENT SETTING TOO LOW. HOMECHOICE APD SYSTEMS TRAINER'S GUIDE. SECTION 12 "PROGRAMMING A PRESCRIPTION" IN 12.3.3 ON PAGE 12-6 GIVES THE WARNING THAT "IF YOU SET THE MINIMUM DRAIN VOLUME% TOO LOW, AN INCOMPLETE DRAIN COULD RESULT FOR THE PATIENT. THIS COULD CAUSE AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION." IF ANY ADDITIONAL 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 AT 21:15:07. DURING NIGHT DRAIN CYCLE EIGHT, THE PATIENT'S ULTRAFILTRATION READING WAS 1346ML, INDICATING THE HOME PATIENT (HP) DRAINED 1346ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
135794	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1