FDA Adverse Event Malfunction Summary report: N

HOMECHOICE

MDR report key: 3812080 · Received May 15, 2014

Report

Report Number: 1416980-2014-15487
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 21, 2014
Report Date: April 21, 2014
Manufacturer: BAXTER HEALTHCARE - LARGO
Product Code: FKX
PMA / PMN Number: K102936
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS THE DEVICE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. A SERVICE HISTORY REVIEW WAS PERFORMED AND ALTHOUGH THERE WERE OTHER FAILURES IDENTIFIED DURING PREVIOUS SERVICING, THE REPORTED ISSUE WAS TOO VAGUE TO BE ABLE TO DETERMINE A DIRECT RELATIONSHIP. THEREFORE, A REVIEW OF THE SERVICE HISTORY COULD NOT DETERMINE IF ANY PREVIOUS SERVICING EVENTS COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED ALARM COULD NOT BE VERIFIED AND THE CAUSE OF THE ALARM COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

A CUSTOMER REPORTED RECEIVING AN UNIDENTIFIED ALARM CODE DURING THE USE OF THE HOMECHOICE DEVICE, DURING DWELL. THIS ALARM OCCURRED JUST PRIOR TO THE PATIENT RECEIVING A SYSTEM ERROR 2265. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290212	HOMECHOICE	SYSTEM, PERITONEAL, AUTOMATIC DELIVERY	FKX	BAXTER HEALTHCARE - LARGO

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR