FDA Adverse Event Malfunction Summary report: N

HOMECHOICE CYCLER-REFURBISHED

MDR report key: 1891896 · Received November 5, 2010

Report

Report Number: 1423500-2010-05360
Event Type: Malfunction
Date Received: November 5, 2010
Date of Event: October 13, 2010
Report Date: October 13, 2010
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, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE FAILED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL GROUND BOND TEST. THE PRODUCT ANALYSIS LAB EVALUATED THE DEVICE AND ALL GROUND RESISTANCE MEASUREMENTS WERE WITHIN THE GROUND BOND SPECIFICATION. THE ASSIGNABLE CAUSE FOR RITE TEST FAILURE - GROUND BOND WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. NO ISSUES WERE IDENTIFIED DURING MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, THE PRODUCT ANALYSIS LABORATORY DETERMINED THE HC MACHINE SYSTEM FAILED RETURNED INSTRUMENT TEST/EVALUATION TESTING DUE THE DEVICE FAILED THE GROUND BOND TEST INDICATING A HIGH RESISTANCE VALUE BETWEEN THE HC AND THE GROUND BOND ON THE POWER SUPPLY.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1