FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3843752 · Received June 2, 2014

Report

Report Number: 1416980-2014-17657
Event Type: Malfunction
Date Received: June 2, 2014
Date of Event: January 26, 2014
Report Date: May 8, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: EZ
Reporter Occupation: OTHER

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 INCREASED INTRA PERITONEAL VOLUME (IIPV) EVENT WAS CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE ROOT CAUSE COULD NOT BE IDENTIFIED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A HIGH DRAIN ERROR 112 (NIGHT DRAIN #12) ALARM WAS IDENTIFIED IN THE LOG. THIS ALARM INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE, INDICATING AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE ALARM OCCURRED ON (B)(6) 2014 AT 07:45:51. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321459	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1