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

Catalog Number 5C8310

Device Problem Air/Gas in Device (4062)

Patient Problems Dyspnea (1816); Abdominal Distention (2601)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported an automated peritoneal dialysis patient felt bloated and had breathing difficulty during an unknown process step of therapy.The patient was connected to the homechoice pro device at the time of the events.The patient further reported they felt ¿symptoms of air¿ and that the air was cleared without troubleshooting assistance.Renal therapy services initiated the swap of the device and continuous ambulatory peritoneal dialysis was discussed.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Integrity and all pressures were correct and stable, no leaks were found.Priming sequence with an unmodified set was completed, and no air was noted in the lines.A short, simulated therapy was successfully performed.The sample analysis was performed, and the device was found to meet specifications for the reported event.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported issue was not verified.The cause of the condition could not be determined.Based on additional information received, the homechoice pro was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 18465140
• MDR Text Key: 332320203
• Report Number: 1416980-2024-00013
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other