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

Catalog Number ASKU

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

Patient Problem Peritonitis (2252)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter postal code: 1420 d1: the reported product is an unknown baxter titanium adapter the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.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

It was reported three days prior to starting peritoneal dialysis (pd) therapy, the patient experienced a disconnection between the titanium adapter and the transfer set which resulted in peritonitis.The peritonitis was manifested by cloudy fluid.It was reported the transfer set became detached from the adapter and ¿fell to the ground¿.The patient then screwed the transfer set to the catheter.According to the reporter, the ¿extender¿ was changed.It was not reported if the patient was hospitalized for the event.The patient received intraperitoneal vancomycin and ceftazidime for the event.At the time of this report, the peritonitis was resolving.Action with pd therapy was not reported.It was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.

• 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: 18696469
• MDR Text Key: 335260802
• Report Number: 1416980-2024-00513
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 02/13/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHYSIONEAL 1.36%; TRANSFER SET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male