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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 03/07/2024

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient experienced peritonitis manifested by cloudy fluid and abdominal pain.On an unreported date, the patient was hospitalized (due to cloudy fluid and abdominal pain) and was treated with a start dose of intraperitoneal (ip) vancomycin injection (1gm) and ip amikacin injection (100mg) followed by imipenem injection (500mg, one bag/day) and amikacin injection (50mg, one bag/day) for the event.The cause of the event, patient outcome and action taken with pd therapy were not reported.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon follow-up, it was reported that the cause of peritonitis was due to a breach in aseptic technique.The breach in aseptic technique was not further described.On an unknown date, the patient was discharged from the hospital and antibiotic treatment was discontinued.At the time of this report, the patient recovered from abdominal pain and was recovering from peritonitis.On an unreported date, pd therapy was discontinued, the pd catheter was removed and the patient was transferred to hemodialysis.It was reported the patient was retrained for proper aseptic technique.H10: 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.

• 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: 19006592
• MDR Text Key: 338980511
• Report Number: 1416980-2024-01424
• 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: 05/03/2024

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: 03/08/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/03/2024
• 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%; DIANEAL 2.5%; UNKNOWN BAXTER PD DISPOSABLES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female