FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 2034040 · Received March 30, 2011

Report

Report Number: 1423500-2011-03836
Event Type: Malfunction
Date Received: March 30, 2011
Date of Event: March 7, 2011
Report Date: March 8, 2011
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K053512
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE FAILED THE RITE (RETURN INSTRUMENT TEST/EVALUATION) DUE TO GROUND BOND FAILED PERFORMANCE SPECIFICATION. THE CAUSE WAS DETERMINED TO BE A LOOSE SETSCREW ON THE DOOR POST. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE RITE FAILURE. THE DOOR POST AND DOOR COVER WILL BE SCRAPPED DURING SERVICE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

DURING EVALUATION OF THE HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE TO THE FOLLOWING FAILURE: GROUND BOND FAILED PERFORMANCE SPECIFICATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1