MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8310R

Device Problems Degraded (1153); Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The homechoice (hc) device was returned and evaluated by the product analysis lab (pal).An event history review was conducted and there were no keystrokes, programming, or use related events that indicated and/or contributed to the problem.The external and internal inspection was performed with no issues noted.Temperature was within specifications.The device passed electrical testing.A volumetric accuracy test was performed and the device failed.Test article, piston foam, was installed and the device passed the volumetric accuracy test.The evaluation revealed the cause of the failure to be deteriorated piston foam.The piston foam was to be scrapped and the device was sent for servicing.A capa was reference to investigate this event.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

During evaluation of a returned homechoice (hc) device, a baxter technician determined the hc machine failed the volume accuracy test.Device failed during evaluation, no patient involved.

Manufacturer Narrative

(b)(4).The homechoice (hc) was returned and is currently in the process of being evaluated.Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4182401
• MDR Text Key: 12579075
• Report Number: 1416980-2014-36356
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1