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

Catalog Number 5C4471R

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

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the evaluation of the returned device is complete.An internal and external inspection was performed with no abnormalities noted.The homechoice device received a returned instrument testing evaluation (rite). this evaluation included functional and electrical testing of the device.The failed fluid volume accuracy test occurred during functional rite.An event history log review was performed and showed no keystrokes, programming, or use related events that indicated and/or contributed to the issue. a service history review was conducted and there were no deviations noted during the service of this device that could have caused or contributed to the issue.The cause of the functional rite test failure was determined to be a deteriorated door piston foam and a cracked door piston.The device will be serviced to meet specifications.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• 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: 4167185
• MDR Text Key: 4874798
• Report Number: 1416980-2014-35657
• 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: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2014
• 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