MAUDE Adverse Event Report: BAXTER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Insufficient Information (3190)

Patient Problem Pneumonia (2011)

Event Type  malfunction  

Event Description

The patient was hospitalized on (b)(6) 2018 due to infectious pneumonia and is currently in-patient.Patient uses a baxter peritoneal dialysis system at home.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER
• MDR Report Key: 17534478
• MDR Text Key: 321456272
• Report Number: MW5141378
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1