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 12/12/2023

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event: "9 decades." 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 peritonitis.The breach in aseptic was further described as¿ break in aseptic technique was noted during pd procedures¿.It was reported the patient was hospitalized for the event.It was unknown if the patient received treatment.It was reported the patient recovered from the peritonitis.Pd therapy was ongoing.It was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.

Manufacturer Narrative

Upon follow-up, it was reported that the peritonitis was manifested by cloudy effluent.The patient was treated with ceftazidime for the event (for 15 days).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: 19173654
• MDR Text Key: 340937832
• Report Number: 1416980-2024-01885
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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
• Date Manufacturer Received: 03/29/2024
• 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; REGUNEAL LCA 2.5; TSUNAGU UV DEVICE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male