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

Catalog Number 5C8310

Device Problem Filling Problem (1233)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.An internal and external inspection was completed and revealed the door cover was damaged.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Homechoice return instrument test/evaluation (rite) electrical testing was performed and revealed no issues or errors and all tests passed.Rite functional testing was performed and the device failed accuracy confirmation.The device did not meet product specification related to the rite failure.The assignable cause was determined to be deteriorated piston foam.To correct the condition, the piston foam was replaced.The device was serviced to meet functional specification.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) accuracy confirmation testing indicating an over delivery of solution from the homechoice pro.The accuracy confirmation test exceeded the rite specified limits of fill/drain 1 volume range and fill/drain 2 volume range.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 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7212341
• MDR Text Key: 98078506
• Report Number: 1416980-2018-00317
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• 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: 11/16/2017
• Date Manufacturer Received: 01/09/2018
• 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