FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 2252347 · Received September 17, 2011

Report

Report Number: 1423500-2011-12359
Event Type: Malfunction
Date Received: September 17, 2011
Date of Event: August 30, 2011
Report Date: August 30, 2011
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
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 AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Additional Manufacturer Narrative · 1

(B)(4). DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE GROUND BOND TEST. GROUND BOND TEST MEASURED 99 OHMS (RANGE IS 0.001 TO 0.100 OHM). TECHNICIAN MEASURED GROUND FROM POWER ENTRY MODULE TO DOOR POST USING A MULTIMETER AND THE MEASUREMENT WAS 92.02 OHMS; INSPECTED DOOR POST AND FOUNDS LOOSE DOOR POST. THE DEVICE HISTORY FOR PREVIOUS RETURN SHOWED THE PREVIOUS RETURN UNRELATED TO THE GROUND BOND FAILURE. THE ASSIGNABLE CAUSE FOR GROUND BOND FAILURE WAS DETERMINED TO BE THE LOOSE DOOR POST. DOOR POST WILL BE SCRAPPED DURING SERVICING. DEVICE WAS SENT TO SERVICING.

Description of Event or Problem · 1

DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE 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	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1