MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114364

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Malaise (2359)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter first name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 20 minutes prior to completion of a 4hour treatment with an ak 96, the patient became ¿very uncomfortable and cannot bear¿.The treatment was interrupted and the extracorporeal blood was returned to the patient.Post treatment weight recording showed 43.2kg indicating that the patient had sustained almost 1l excessive fluid removal.No alarm condition was reported in connection with the treatment.Treatment was not reported.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated onsite by a hospital engineer and found a liquid leak from the silicon connector from the degassing chamber that was cracked.The engineer replaced the silicon connector and degassing chamber, adjusted (calibrated) the ultrafiltration cell and variable flow.A simulation and functional test was performed and the device passed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 96
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12527617
• MDR Text Key: 273174456
• Report Number: 9616026-2021-00053
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR