FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 2981314 · Received February 27, 2013

Report

Report Number: 1416980-2013-04821
Event Type: Malfunction
Date Received: February 27, 2013
Date of Event: October 29, 2012
Report Date: February 2, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Removal / Correction Number: 1423500-01/08/10-001-C
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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 FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE CAUTION: NEGATIVE UF ALARM. THE LABELING WARNS THE PATIENT TO NOT BYPASS THIS ALARM EXCEPT ON THEIR DIALYSIS CENTER?S ADVICE. BYPASSING A CAUTION: NEGATIVE UF ALARM CAN LEAVE FLUID IN THE PERITONEAL CAVITY AND RESULT IN AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION. IF ANY 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) 2012 12:04:40. DURING NIGHT DRAIN CYCLE TWO, THE PATIENT'S ULTRAFILTRATION READING WAS 726ML, INDICATING THE HOME PATIENT (HP) DRAINED 726ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 800ML. THIS INFORMATION MEETS IIPV CRITERIA. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84016	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1