FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3840539 · Received May 30, 2014

Report

Report Number: 1416980-2014-17370
Event Type: Malfunction
Date Received: May 30, 2014
Date of Event: May 5, 2014
Report Date: May 5, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED, ALONG WITH ALL OF THE ELECTRICAL TESTING. THE FLUID VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED; THEREFORE, PAL PERFORMED A MORE DETAILED INSPECTION OF THE DOOR ASSEMBLY. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED. THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE THE DETERIORATED PISTON FOAM. THE PISTON FOAM WAS REPLACED TO RESOLVE THE CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN EVALUATION OF A RETURNED HOMECHOICE DEVICE, THE DEVICE FAILED VOLUMETRIC ACCURACY TESTING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
318810	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1