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 09/24/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The homechoice (hc) device evaluation was completed.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to this return instrument test/evaluation (rite) failure.A review of the service history revealed no failures or problems that were the same as, or similar to the rite failure and there was no indication that the parts replaced during servicing caused or contributed to this event.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 door piston foam was too deteriorated to place back into the device.An inspection of the door assembly found the door piston cracked on the top edge and at the left disposable.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 and the device was sent for servicing.This issue is being further investigated through a capa.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 rite (returned instrument test/evaluation) testing for fluid volume accuracy.Device failed during evaluation, no patient involved.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 - 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: 4184503
• MDR Text Key: 12519487
• Report Number: 1416980-2014-36439
• 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: 09/24/2014

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: 10/22/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2014
• 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