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

Catalog Number 5C4471

Device Problems Break (1069); Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2015

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.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned to baxter, and the evaluation is complete.This is an ancillary service event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the discovered issue.An internal/external inspection was performed and the device passed.Temperature confirmation testing was performed and the device passed.Rite (returned instrument test evaluation) electrical testing was conducted and the device passed.The device failed volumetric accuracy testing associated with rite functional testing.Test piston foam was installed and the device was able to pass the volumetric accuracy test.Pneumatic system testing found no issues.When the original piston foam was reinstalled, the device failed the volumetric accuracy testing again.The original piston foam was removed and inspection found that the piston foam was deteriorated and the door piston was cracked.The cause of the reported issue was due to the deteriorated piston foam and the cracked door piston.The device was sent for servicing.Should additional relevant information become available, a supplemental 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4488259
• MDR Text Key: 5327892
• Report Number: 1416980-2015-04457
• 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: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Date Manufacturer Received: 01/09/2015
• 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