FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3802404 · Received May 9, 2014

Report

Report Number: 1416980-2014-14915
Event Type: Malfunction
Date Received: May 9, 2014
Date of Event: April 15, 2014
Report Date: April 15, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
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 (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 THE DEVICE PASSED, ALONG WITH ALL OF THE ELECTRICAL TESTING. THE TEMPERATURE WAS VERIFIED TO BE WITHIN SPECIFICATIONS. DURING THE EVALUATION, THE FLUID WAS TRANSFERRED ABOVE THE RITE (RETURNED INSTRUMENT TEST EVALUATION) SPECIFIED LIMITS AND THE VOLUMETRIC ACCURACY TEST THAT FOLLOWED, SHOWED THAT THE DEVICE HAD FAILED. PAL PERFORMED A MORE DETAILED INSPECTION OF THE DOOR ASSEMBLY. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED. THE RESULTS OF 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 EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281458	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1