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 02/10/2024

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. 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 not further described.The peritonitis was manifested by cloudy pd effluent and abdominal pain.Two days after the event onset, the patient was hospitalized and treated with vancomycin injection (1gm, every 5th day, intraperitoneal, ongoing) for the event.At the time of this report, the patient remained hospitalized and was recovering from the events.Pd therapy was ongoing.It was reported that the patient was retrained on the proper aseptic technique.No additional information is available.

Manufacturer Narrative

B5: upon follow-up, it was reported that on an unknown date, antibiotic treatment was discontinued, the patient was discharged from the hospital and was recovered from the events.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: 18851763
• MDR Text Key: 337068508
• Report Number: 1416980-2024-00980
• 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: 05/09/2024

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: 02/12/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/09/2024
• 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 PD4 1.5%; DIANEAL PD4 2.5%; UNKNOWN BAXTER PD DISPOSABLES; UNKNOWN PD CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male