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 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.During returned instrument testing evaluation (rite), an external inspection was performed and no issues were noted.Functional testing was performed with no issues noted.Electrical testing was performed and failed the ground bond test which revealed the device was out of specifications for the resistance measured.Further inspection revealed the cause of the condition was due to a loose door post.The door post was tightened to resolve the reported condition.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the condition.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: 8519865
• MDR Text Key: 142130804
• Report Number: 1416980-2019-02054
• 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
• Report Date: 04/16/2019

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: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/16/2019
• 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