MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Peritonitis (2252); Swelling/ Edema (4577)

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 the connection point was opened and there was hand contact.The patient was hospitalized for 15 days and treated with unspecified antibiotics for the event.At the time of this report, the patient was discharged from the hospital and recovered from peritonitis.Pd therapy was ongoing.It was not reported if 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, b6, and h6.B5: upon follow-up, it was reported that the patient also experienced edema during the peritonitis event (approximately 1.5 months ago).At the time of this report, the patient had recovered from edema.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: 18671349
• MDR Text Key: 334924123
• Report Number: 1416980-2024-00437
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 02/22/2024

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2024
• 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.; HC DISPOSABLE WITH CASSETTE.; HOMECHOICE CLARIA DEVICE.; PHYSIONEAL 2.27%.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female