FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3151487 · Received June 7, 2013

Report

Report Number: 1416980-2013-14593
Event Type: Malfunction
Date Received: June 7, 2013
Date of Event: May 30, 2013
Report Date: May 30, 2013
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE DEVICE FAILED THE HC RETURN INSTRUMENT TEST/EVALUATION (RITE) ELECTRICAL TEST DUE TO FAILED GROUND BOND VERIFICATION BUT PASSED RITE FUNCTIONAL TEST. THE DEVICE WAS RECEIVED IN OPERATIVE AND IN GOOD CONDITION. AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. THE DEVICE POWERED UP PROPERLY AND NO ERRORS OCCURRED. PERFORMED CONTINUITY TEST BETWEEN POWER ENTRY MODULE (PEM) GROUND AND DOOR POST AND RESISTANCE WENT FROM 0.228 TO 0.001 OHMS WHEN THE SCREW WAS COMPLETELY TIGHTENED. THE LOOSE DOOR POST CAUSED A POOR CONNECTION BETWEEN THE PEM GROUND AND DOOR POST RESULTING IN THE GROUND BOND FAILURE. THE CAUSE FOR THE RITE FAILURE OF GROUND BOND FAILURE WAS DETERMINED TO BE CAUSED BY A LOOSE DOOR POST SET SCREW. DOOR POST WOULD BE SCRAPPED AND THE DEVICE WAS SENT TO SERVICING. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

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. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
252487	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1