MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO 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 01/22/2015

Event Type  malfunction  

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 homechoice device was returned and evaluated by the product analysis lab (pal).A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.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 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.Upon further inspection, it was determined that the cause of the failure was due to deteriorated piston foam.The piston foam was to be scrapped and the device was sent for servicing.A capa has been opened to address this issue.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 - 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: 4528246
• MDR Text Key: 5544187
• Report Number: 1416980-2015-06314
• 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: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• 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: 01/22/2015
• Date Manufacturer Received: 01/22/2015
• 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