FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3840517 · Received May 30, 2014

Report

Report Number: 1416980-2014-17372
Event Type: Malfunction
Date Received: May 30, 2014
Date of Event: May 6, 2014
Report Date: May 6, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE HOMECHOICE WAS RECEIVED, AND A DEVICE ANALYSIS IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL 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 WITH NO ISSUES NOTED. TEMPERATURE WAS WITHIN SPECIFICATIONS. THE DEVICE PASSED ELECTRICAL TESTING. A VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. TEST ARTICLE, PISTON FOAM, WAS INSTALLED AND THE DEVICE PASSED THE VOLUMETRIC ACCURACY TEST. THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE DETERIORATED PISTON FOAM. THE PISTON FOAM WAS TO BE SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THERAPY MONITORED FLUID VOLUME TESTING. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
319497	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1