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

Catalog Number 5C8310

Device Problem Grounding Malfunction (1271)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

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 and electrical testing were performed.Rite electrical testing failed the ground bond test which revealed the device was out of specifications for the resistance measured.The inspection revealed the cause of the failure was due to a loose and detached door ground wire.The door ground wire was replaced to resolve the 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 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 PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore ; SN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8460327
• MDR Text Key: 140440728
• Report Number: 1416980-2019-01630
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• 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