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 Type  Injury  

Manufacturer Narrative

B3: the event occurred on an unreported date in sep2023.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 technique was further described as the patient either touched their hand or forgot to wear their mask during contention.The patient was initially hospitalized for one week due to the event, went back home for three days and then back to the hospital again for three weeks.The patient was later discharged and a few days later was hospitalized again for another seven weeks.Treatment, patient outcome, action taken with pd therapy and patient retraining on the proper aseptic technique were not reported.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 60073 ; 2242702068
• MDR Report Key: 18584701
• MDR Text Key: 333772030
• Report Number: 1416980-2024-00177
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2024

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: 01/02/2024
• Initial Date FDA Received: 01/25/2024
• 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: AMIA CASSETTES.; CYCLER.; DIANEAL 1.5% AMBUFLEX.; DIANEAL 2.5% AMBUFLEX.; EXTRANEAL 7.5% AMBUFLEX.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female