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 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation and an evaluation is complete.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.An event history log review was performed and showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A homechoice return instrument test/evaluation (rite) functional test was completed and there no issues or errors, and all tests passed.An internal and external inspection was completed and revealed loose wires at the terminal of the door assembly.Rite electrical testing failed the ground bond test.The device did not meet product specification related to the rite failure.The assignable cause was determined to be loose ground wire at the ground terminal of the door assembly.The loose wires were replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned homechoice pro device, a baxter technician determined the homechoice pro machine failed the returned instrument test evaluation (rite) ground bond test indicating a high resistance value between the homechoice pro and the ground bond on the power supply.The ground bond resistance exceeded the rite specified limits at 0.149.The device failed during evaluation, there was no patient involvement.

• 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 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7332433
• MDR Text Key: 102202820
• Report Number: 1416980-2018-01298
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• 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: 12/01/2017
• Date Manufacturer Received: 02/19/2018
• 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