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

Catalog Number 5C8310

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

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2014

Event Type  malfunction  

Event Description

During evaluation of a returned homechoice (hc) device, a baxter technician determined the hc 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 (hc) device was returned and evaluated by the product analysis lab (pal).The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A review of the device history records revealed no issues that could have caused or contributed to the reported difficulty.The external/internal inspection was performed and the device passed, along with all of the electrical testing.The fluid volumetric accuracy test that was performed, had failed with the original piston foam.However, when a test article, piston foam, was installed, the device passed the accuracy confirmation testing.The original piston foam was removed and inspection revealed a cracked door piston and a deteriorated piston foam.The evaluation concluded that the cause of the failed fluid volume accuracy testing was the deteriorated piston foam and a cracked door piston.The piston foam and the door piston were to be scrapped.This issue is being further investigated through a capa.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 - 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: 4215194
• MDR Text Key: 5148744
• Report Number: 1416980-2014-38051
• 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
• Report Date: 10/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Date Manufacturer Received: 10/05/2014
• 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