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 12/18/2023

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 further described as due to a hygiene issue.The peritonitis was manifested stomach pain and dark effluent.The patient presented to the emergency department; however, the patient was not hospitalized for the event.On an unknown date, the patient was initially treated with ceftazidime (discontinued).On an unknown date, the month of the peritonitis onset, the patient was treated with vancomycin (intraperitoneal, 2 g every five days, ongoing).Approximately two months after event onset, the patient experienced dark effluent.No other symptoms were noted.It was reported that the "patient did not really recover from the first episode of peritonitis".The patient was treated with unspecified intraperitoneal antibiotics and heparin.At the time of the report, the patient was recovering from peritonitis.It was not reported if the patient was retrained on the proper aseptic technique.Pd therapy was ongoing.No additional information is available.

Manufacturer Narrative

B3: the events occurred on 18dec2023 and 20feb2024.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: 18987604
• MDR Text Key: 338723711
• Report Number: 1416980-2024-01375
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

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
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• 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: CASSETTE; DIANEAL 1.5% PD4; DIANEAL 2.5% PD4 (AS NEEDED); DIANEAL 4.25% PD4 (AS NEEDED); EXTRANEAL 7.5%; MINI-CAP
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male