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

Catalog Number 5C4471

Device Problem Grounding Malfunction (1271)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

The homechoice device was returned and evaluated by the product analysis lab (pal).The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.An external inspection was performed and the device passed, along with all of the functional testing.During evaluation, the ground bond failure analysis revealed that the device was out of specified limits for the resistance measured during the returned instrument testing evaluation electrical testing.Pal tightened the screw to the door post and the resistance dropped to be within specification.The inspection revealed the cause of the failure to be a loose door post screw.The door post screw was re-torqued to correct the issue.There was an additional unrelated issue found of fluid ingress on the digital board.The digital board was replaced.The device was sent for service.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 the ground bond test indicating a high resistance value between the device and the ground bond on the power supply.There was no patient involvement.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: 7814447
• MDR Text Key: 118326041
• Report Number: 1416980-2018-05381
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• 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: 07/12/2018
• Date Manufacturer Received: 08/18/2018
• 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