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 04/06/2024

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 manifested by cloudy pd effluent.The breach in aseptic technique was not further specified.On the same day as the event onset, the patient was hospitalized and was treated with vancomycin injection (1g, every 72 hours, intraperitoneal, ongoing), amikacin injection (125mg, intraperitoneal, once a day,ongoing), and fluconazole tablet (150mg, oral, once a day, ongoing) for the event.It was reported that the patient was recovering from the event.Pd therapy was ongoing.The patient was retrained for proper aseptic technique.No additional information is available.

Manufacturer Narrative

B5: upon follow-up, it was reported that the patient recovered from peritonitis.On unknown date, the patient was discharged from the hospital and antibiotic therapy was discontinued.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: 19215804
• MDR Text Key: 341421090
• Report Number: 1416980-2024-02001
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• 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
• Date Manufacturer Received: 04/07/2024
• 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 7.5% PD2; MITRA 1.5% PD2; MITRA 2.5% PD2; UNKNOWN BAXTER PD DISPOSABLE; UNKNOWN PD CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male