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

Catalog Number 5C4471R

Device Problems Degraded (1153); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The homechoice device was returned and an evaluation was completed.A device history record review was performed and revealed no issues that could have caused or contributed to the reported problem.Temperature confirmation 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.A visual inspection of original piston foam was performed and revealed that the piston foam was deteriorated.Upon conclusion of the investigation, the cause of the failure was determined to be the deteriorated piston foam and cracked door piston.The piston foam and door piston were scrapped and the device was sent for servicing.This issue will be further investigated through 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 fluid volume accuracy testing.Device failed during evaluation, no patient involved.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Upon completion of baxter's investigation, if additional relevant information is obtained, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• 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: 4166960
• MDR Text Key: 12589919
• Report Number: 1416980-2014-35642
• 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: 09/18/2014

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: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2014
• 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