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 09/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned to baxter, and the evaluation was completed.No abnormalities were identified during internal/external inspection.Temperature confirmation testing was performed and the results were found to be within specifications.Electrical returned instrument test evaluation (rite) was conducted and the device passed.The failure of the fluid volume accuracy test occurred during functional rite, as fluid was transferred above the allowable specification range.A service history record review did not identify any issues in the previous service events that would have contributed to the reported issue.The cause of the volumetric accuracy failure was determined to be due to a deteriorated piston foam and cracked door piston.The piston foam and door piston was scrapped.Should additional relevant information become available, a supplemental 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.

Manufacturer Narrative

(b)(4).The homechoice was received and an evaluation is being performed.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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4141315
• MDR Text Key: 12576214
• Report Number: 1416980-2014-34480
• 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: 09/09/2014

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: 09/08/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2014
• 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