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

Catalog Number 5C4471

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.External visual inspection was performed with no issue noted.An internal visual inspection revealed a damaged door handle, a cracked door bezel, deteriorated piston foam, a cracked piston, deteriorated membrane gasket, deteriorated pump foam pad, a damaged occluder boot, and debris in pump filter and pump tubing.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device met electrical performance specification requirements per rite testing; however failed function testing for volumetric accuracy.An accuracy confirmation test was performed and failed.The cause was deteriorated piston foams.The piston foam was to be scrapped and the device was sent for servicing.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

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.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7077168
• MDR Text Key: 93625185
• Report Number: 1416980-2017-09520
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 10/12/2017
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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