FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 4790254 · Received May 22, 2015

Report

Report Number: 1416980-2015-22444
Event Type: Malfunction
Date Received: May 22, 2015
Date of Event: May 6, 2015
Report Date: May 6, 2015
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE EVENT. AN INTERNAL/EXTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. FUNCTIONAL TESTING, ELECTRICAL TESTING, CURRENT LEAKAGE TESTING, AND IMPEDANCE TESTING WAS PERFORMED. THE REPORTED CONDITION WAS VERIFIED. THE INSPECTION SHOWED THAT THE PUMP WAS DEFECTIVE. THE RESULTS OF THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE THE DEFECTIVE PUMP. THE PUMP WAS TO BE SCRAPPED AND THE DEVICE WAS SENT FOR SERVICING. A CAPA CURRENTLY EXISTS TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN DETERMINED THE DEVICE FAILED THE EARTH LEAKAGE CURRENT TEST. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
334787	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1