FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3802826 · Received May 9, 2014

Report

Report Number: 1416980-2014-14986
Event Type: Malfunction
Date Received: May 9, 2014
Date of Event: April 15, 2014
Report Date: April 15, 2014
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. INTERNAL/EXTERNAL INSPECTIONS WERE PERFORMED AND THE DEVICE PASSED. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE DEVICE PASSED. RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING WAS CONDUCTED AND THE DEVICE PASSED. THE DEVICE FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE THE ALLOWABLE SPECIFICATION RANGE. THE DOOR ASSEMBLY WAS INSPECTED WHICH REVEALED DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. THE CAUSE OF THE RITE FAILURE WAS DUE TO DETERIORATED PISTON FOAM. THE PISTON FOAM AND DOOR PISTON WAS SCRAPPED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL 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
280116	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1