FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3830728 · Received May 23, 2014

Report

Report Number: 1416980-2014-16842
Event Type: Malfunction
Date Received: May 23, 2014
Date of Event: May 1, 2014
Report Date: May 1, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION RESULTS ARE PENDING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTING. EXTERNAL AND INTERNAL VISUAL INSPECTIONS WERE PERFORMED AND FOUND NO ISSUES. THE PNEUMATIC SYSTEM WAS TESTED AND FOUND NO ISSUES. A SIMULATED THERAPY WAS PERFORMED ON THE DEVICE SUCCESSFULLY. THE REPORTED ISSUE WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A HIGH DRAIN 104 ALARM OCCURRED DURING DRAIN FOUR ON THE HOME CHOICE (HC). THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE AND DISCUSSED THE USE OF MANUAL SUPPLIES TO COMPLETE THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
308101	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR