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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Sepsis (2067); Peritonitis (2252)

Event Date 12/17/2023

Event Type  Death  

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

Event Description

A peritoneal dialysis (pd patient experienced a breach in aseptic technique which resulted in bacterial peritonitis.The breach in aseptic technique was not further described.The peritonitis was manifested by abdominal pain and cloudy pd fluid bag (which occurred a day prior to the peritonitis diagnosis).It was not reported if the patient was hospitalized for the event.The same day as the peritonitis diagnosis, the patient was treated with vancomycin injection (1gm, every 72 hours, intraperitoneal, ongoing), ceftazidime injection (500mg every 10pm, 250mg every 2pm and 250mg every 6am, intraperitoneal, ongoing) for the event.On an unknown date, the patient experienced septicemia.Treatment for the event was not reported.It was reported nine days after the peritonitis diagnosis, the patient passed away.The cause of death was reported as due to septicemia.It was not reported if an autopsy was performed.It was reported that the patient has not recovered from cloudy pd fluid bag and abdominal pain; however the patient was recovering from peritonitis.It was reported retraining on the proper aseptic technique was ongoing.Pd therapy was ongoing prior to and at the time of death.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 CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18478409
• MDR Text Key: 332463514
• Report Number: 1416980-2024-00025
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2023
• Initial Date FDA Received: 01/09/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIANEAL 2.5% PD2; UNKNOWN BAXTER PD DISPOSABLES
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female