FDA Adverse Event Malfunction Summary report: N

HOMECHOICE PRO

MDR report key: 3840167 · Received May 30, 2014

Report

Report Number: 1416980-2014-17351
Event Type: Malfunction
Date Received: May 30, 2014
Report Date: May 5, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE REPORTED PROBLEM WAS IDENTIFIED AS A LOW DRAIN ALARM. THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG WAS PERFORMED. THE REPORTED CONDITION OF NUMEROUS ALARMS WAS IDENTIFIED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND A SIMULATED THERAPY WERE PERFORMED WITH NO ISSUES NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT UNSPECIFIED ALARM OCCURRED DURING USE ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. 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
318651	HOMECHOICE PRO	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1