FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 2990353 · Received March 5, 2013

Report

Report Number: 1416980-2013-05308
Event Type: Malfunction
Date Received: March 5, 2013
Date of Event: February 20, 2013
Report Date: February 20, 2013
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). ACCURACY TEST FAILED WITH THE ORIGINAL PISTON FOAM; HOWEVER, ACCURACY TEST PASSED WITH TEST ARTICLE FOAM. TEMPERATURE CONFIRMATION TEST PASSED. AN INSPECTION OF THE DOOR ASSEMBLY REVEALED DETERIORATED PISTON FOAM. THE ASSIGNABLE CAUSE FOR THE RITE ISSUE WAS DETERMINED TO BE DETERIORATED PISTON FOAM. DEVICE WILL BE SENT TO SERVICING.

Description of Event or Problem · 1

THE PRODUCT ANALYSIS LABORATORY (PAL) DETERMINED THE HOMECHOICE (HC) MACHINE SYSTEM FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO A RITE - THERAPY MONITORED VOLUME FAILED PERFORMANCE SPECIFICATION. RITE TEST FAILURE WAS FOUND BY SERVICE PERSONNEL DURING EVALUATION, NO PATIENT WAS INVOLVED. NO ADDITIONAL INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
93346	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1