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

Device Problem Fitting Problem (2183)

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

Event Date 09/30/2023

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) transfer set had a connection issue which resulted in bacterial peritonitis.The connection issue was further described as, ¿thread was not fully covered by transfer set¿.The peritonitis was manifested by abdominal pain and cloudy effluent.It was not reported if the patient was hospitalized for peritonitis.On the same day as the onset, the patient was treated with cephazolin (intraperitoneal, at a dose of four times a day) for peritonitis.At the time of this report, treatment was ongoing, and the patient was recovering from peritonitis.The action taken with pd therapy was unknown.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.The most probable cause of the event is due to a device use issue, as it was reported that the thread was not fully covered by transfer set and patient technique failure.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: TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18025228
• MDR Text Key: 326793447
• Report Number: 1416980-2023-05528
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DIANEAL; EXTRANEAL
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male