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 Date 12/19/2023

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 not further described.The peritonitis was manifested by turbid pd fluid.The peritonitis was confirmed five days after the initial symptom onset.It was reported that the patient was not hospitalized for the event.A day after the initial symptom onset, the patient was treated with vancomycin injection (1gm, every 5th day, for 15 days, ongoing) and amikacin injection (500mg, intraperitoneal, once daily, discontinued on the same day) for the event.Two days after the initial symptom onset, the patient was treated amikacin injection (100mg, intraperitoneal, once daily, for 15 days, discontinued after 9 days) for the event.At the time of this report, the patient has recovered from turbid pd fluid and was recovering from peritonitis.Pd therapy was ongoing.Retraining on the proper aseptic technique was not done yet.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: upon follow-up, it was reported that antibiotic treatment with amikacin injection was discontinued nine days after administration.At the time of this report, the patient has recovered from peritonitis.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon follow-up, it was reported that the patient was treated again with amikacin injection (120mg, once daily, intraperitoneal, discontinued) 12 days after the initial symptom onset.On an unknown date, the patient was treated again with amikacin injection (250mg, once daily, intraperitoneal, ongoing) for peritonitis.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: 18475609
• MDR Text Key: 332442495
• Report Number: 1416980-2024-00022
• 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,Followup
• Report Date: 02/21/2024

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: 12/15/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/08/2024; 01/30/2024
• Supplement Dates FDA Received: 02/01/2024; 02/21/2024
• 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: COVIDIEN CATHETER.; DIANEAL 1.5% PD2.; UNKNOWN BAXTER PD DISPOSABLES.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male