FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3930230 · Received July 11, 2014

Report

Report Number: 1416980-2014-22421
Event Type: Malfunction
Date Received: July 11, 2014
Date of Event: June 16, 2014
Report Date: June 16, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

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. AN EXTERNAL/INTERNAL VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATIONS. A FLUID VOLUMETRIC ACCURACY TEST WAS PERFORMED AND FAILED. HOWEVER, A PISTON FOAM TEST ARTICLE WAS INSTALLED, AND THE DEVICE SUBSEQUENTLY PASSED ACCURACY TESTING. THE ORIGINAL PISTON FOAM WAS REMOVED AND INSPECTION REVEALED A CRACKED DOOR PISTON AND DETERIORATED PISTON FOAM. THE EVALUATION CONCLUDED THAT THE CAUSE OF THE FAILED FLUID VOLUME ACCURACY TESTING WAS THE DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON. THE PISTON FOAM AND THE DOOR PISTON WERE TO BE REPLACED. 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 FLUID VOLUME ACCURACY TESTING. AS THE DEVICE FAILED DURING EVALUATION, NO PATIENT WAS INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
405885	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1