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 12/26/2023

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. 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, malaise, and peritoneal cloudy effluent.The same day as the event onset, the patient was hospitalized and treated with gentamicin (discontinued after 5 days) for the event.On an unknown date, the patient was treated with ciprofloxacin (administered once, intravenously followed by 100mg in 2l of solution, intraperitoneal), levofloxacin (intravenous), sulfamethoxazole, trimethoprim (co-trimoxazole) (at a dose of 24/24 hours, intravenous) for bacterial peritonitis.At the time of this report, the patient had not recovered from the event.On an unspecified date, the pd catheter was removed from the patient and was no longer in the pd program.It was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.

Manufacturer Narrative

Additional information, b5: upon follow-up, it was reported that on an unknown date, the patient was discharged from the hospital and was recovered from the peritonitis event.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: 18609834
• MDR Text Key: 334140746
• Report Number: 1416980-2024-00248
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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: 01/04/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/06/2024
• 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; PHYSIONEAL 40 1.36%
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male