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 10/08/2014

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 was returned and evaluated.No keystrokes, programming, or use related events that indicated and/or contributed to the problem were found during event history log review.Nothing in the service history review was found that would indicate the reported problem.Device evaluated and passed the hc return instrument test / evaluation rite electrical test but failed rite functional test due to therapy monitored volume failed.External/internal inspection was performed and passed.Fluid was transferred above the rite specified limits during fill 1&2, drain 1&2 and last fill.Accuracy confirmation test was performed and failed.Temperature verification test was performed per (b)(4) and passed.Inspected door assembly and found the piston foam deteriorated and cracked door piston.Direct cause for the rite failure of therapy monitored volume failed was determined to be caused by deteriorated piston foam.The piston foam was scrapped.Device was sent to servicing.Should additional relevant information become available, a follow-up 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: 4219557
• MDR Text Key: 18797605
• Report Number: 1416980-2014-38283
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• 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: 10/07/2014
• Date Manufacturer Received: 10/08/2014
• 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