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); Peritonitis (2252); Malaise (2359)

Event Date 01/18/2024

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 further described as poor hygienic conditions of the family.The peritonitis was manifested by general discomfort, mild abdominal pain and cloudy effluent.It was not reported if the patient was hospitalized for the event.The patient was treated with unspecified antibiotics for the event.At the time of this report, the patient has recovered from the event.Action taken with pd therapy and patient retraining on the proper aseptic technique were not reported.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.

• 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: 18695832
• MDR Text Key: 335256499
• Report Number: 1416980-2024-00508
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Report Date: 02/13/2024

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: Not provided
• Initial Date FDA Received: 02/13/2024
• 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: EXTRANEAL 7.5%; PHYSIONEAL 40 1.36%; UNKNOWN BAXTER PD DISPOSABLES
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 15 KG