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 07/19/2021

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. A review of the label for the product family will be conducted. 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 manifested by abdominal pain. The breach in aseptic technique was further described as due to contamination. The patient was hospitalized for the event four days after onset. The patient was treated with unspecified antibiotic (intraperitoneum, dose and frequency were not reported). At the time of this report, hospitalization and treatment were ongoing and the patient has not recovered from the event. It was not reported if the patient was retrained on the proper aseptic technique. No additional information is available.

• 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 ; 2242702068
• MDR Report Key: 12338606
• MDR Text Key: 267141281
• Report Number: 1416980-2021-05104
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: RP
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/18/2021 Patient Sequence Number: 1

Treatment

AMPLODIPINE; CYCLER; CYCLER; DIANEAL 1.5%; DIANEAL 2.5%; FERROUS SULFATE; FOLIC ACID; LOSARTAN; RENVELA