FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3914108 · Received July 3, 2014

Report

Report Number: 1416980-2014-21535
Event Type: Malfunction
Date Received: July 3, 2014
Date of Event: June 11, 2014
Report Date: June 11, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKK
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE HOMECHOICE WAS RETURNED TO BAXTER 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 AND 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 DOOR THE PISTON FOAM WAS DETERIORATED. THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE THE 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 THE EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER SERVICE TECHNICIAN DETERMINED THAT THE H FAILED VOLUMETRIC ACCURACY TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
391446	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKK	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1