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 09/24/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned to baxter and an evaluation was performed.The device passed the homechoice rite (return instrument test/evaluation) electrical test but failed the homechoice rite functional test for volumetric accuracy.A service history review was conducted and there were no deviations noted that could have caused or contributed to the rite failure.Accuracy confirmation test was performed and failed.Temperature verification test was performed and passed.The unit powered up properly and no errors occurred.Inspection of the door assembly found a cracked door piston and deteriorated piston foam.The direct cause for the rite failure of therapy monitored volume failed was determined to be caused by deteriorated piston foam.Direct cause for the additional issue of cracked door piston was undetermined.The door piston and piston foam were scrapped and the device was sent to servicing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned homechoice device, a baxter technician determined the homechoice device failed fluid volume accuracy testing.There was no patient involvement.No additional information is available.¿.

Manufacturer Narrative

(b)(4).The homechoice 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: 4178727
• MDR Text Key: 12496059
• Report Number: 1416980-2014-36128
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2014

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: 09/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 10/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• 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