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)

Event Date 12/11/2023

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis.The breach in aseptic technique was not further described.The peritonitis was manifested by abdominal pain (which occurred a day prior to the peritonitis diagnosis) and cloudy pd fluid (which occurred on the same day as the peritonitis diagnosis).It was reported that the patient was not hospitalized for the events.A day after the peritonitis diagnosis, the patient was treated with meropenem injection (1gm, per bag, intraperitoneal, ongoing) and heparin injection (2000 iu, per bag, intraperitoneal, ongoing) for peritonitis.Two days after the peritonitis diagnosis, the patient has recovered from cloudy pd fluid.At the time of this report, the patient was recovering from abdominal and peritonitis.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 and b6.B5: upon follow-up, it was reported that antibiotic treatment were discontinued (on an unknown date).On an unknown date, pd therapy was discontinued.At the time of this report, the patient has recovered from peritonitis, abdominal pain (on an unknown date) and cloudy pd fluid (two days after the initial symptom onset).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: 18454642
• MDR Text Key: 332198232
• Report Number: 1416980-2023-06949
• 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: 01/29/2024

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: 12/13/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/29/2024
• 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: DIANEAL 1.5% PD2.; DIANEAL 2.5% PD2.; UNKNOWN BAXTER PD DISPOSABLES.; UNKNOWN PD CATHETER.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female