MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO 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 12/13/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).An external/internal inspection was performed with no issues noted.Temperature verification testing was performed and the results were found to be within specifications.The device pneumatic system was evaluated and all pressures were found to be correct and stable.The device was determined to meet electrical performance specification requirements per rite (returned instrument test evaluation) testing.The device failed rite functional testing as fluid was transferred above the allowable specification range during volumetric accuracy testing.Further inspection of the device identified that the cause of the issue was due to degraded piston foam and a cracked door piston.The piston foam and piston were scrapped and the device was sent for servicing.Should additional relevant information become available, a follow-up report will be submitted.

Event Description

During evaluation of a returned homechoice device, a baxter technician determined the device failed fluid volume accuracy testing.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received, and the evaluation is in progress but has not yet been completed.Upon completion of the evaluation, a supplemental 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4387776
• MDR Text Key: 15287377
• Report Number: 1416980-2015-00566
• 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: 12/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 12/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• 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