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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Peritonitis (2252)

Event Date 12/10/2023

Event Type  Injury  

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.On an unknown date, the patient was hospitalized for peritonitis and another indication.The same day as the event onset, the patient was treated with vancomycin injection (1000mg, intraperitoneal, every 3rd day, ongoing) and ceftazidime injection (1000mg, intraperitoneal, once daily, ongoing) for peritonitis.At the time of this report, the patient remained hospitalized and was recovering from the peritonitis event.Pd therapy was ongoing.The patient was retrained on the proper aseptic technique.No additional information is available.

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.

Manufacturer Narrative

Additional information, b5: upon follow-up, it was reported that antibiotic treatment with vancomycin was discontinued.On an unknown date, the patient began treatment again with vancomycin (1000mg, every 3rd, intravenous, ongoing) for peritonitis.On an unknown date, pd therapy was discontinued and the patient was transferred to hemodialysis.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 18465203
• MDR Text Key: 332320726
• Report Number: 1416980-2024-00014
• 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,Followup
• Report Date: 02/14/2024

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: 12/12/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/14/2024
• 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 1.5% PD2; UNKNOWN BAXTER PD DISPOSABLES; UNKNOWN PD CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 12 YR
• Patient Sex: Male