MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problem Peritonitis (2252)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

This report is for a breach in aseptic technique which resulted in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an automated peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis, manifested by cloudy fluid.The breach in aseptic technique was further described as touch contamination.The patient reported they ¿could not close the transfer set all the way¿.It was not reported if the patient was hospitalized for the peritonitis event.The patient was treated with vancomycin (1 gram twice weekly, discontinued after 15 days) and tazicef (1 gram daily, intraperitoneally discontinued after 15 days).The nurse reported the transfer set was replaced.Pd therapy was ongoing.At the time of this report, the patient had recovered from the event.It was reported the patient was retrained on the proper aseptic technique.No additional information is available.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19130473
• MDR Text Key: 340446776
• Report Number: 1416980-2024-01769
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HOME CHOICE CLARIA DEVICE
• Patient Outcome(s): Required Intervention