MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE 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 10/02/2014

Event Type  malfunction  

Event Description

During evaluation of a returned homechoice device, a baxter technician determined the machine failed rite (returned instrument test/evaluation) testing for fluid volume accuracy.Device failed during evaluation, no patient involved.

Manufacturer Narrative

(b)(4).The homechoice was returned and the evaluation is ongoing.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported issue.An internal and external inspection was performed with no abnormalities noted.The device passed the homechoice rite (return instrument test/evaluation) electrical test but failed the homechoice rite functional test.The direct cause of the reported problem was determined to be due to deteriorated piston foam.A service history review was conducted and there were no deviations noted that could have caused or contributed to the reported event during the service of this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4204008
• MDR Text Key: 5037162
• Report Number: 1416980-2014-37613
• 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: 10/02/2014

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: 10/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2014
• 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