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

Catalog Number 110661

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  Injury  

Event Description

It was reported that during treatment with an ak 96 machine, a home dialysis patient had forgotten to clamp the heparin line prior to starting the treatment resulting in external blood loss.The blood leak was observed at the completion of treatment at which time the patient presented with weakness.The amount of blood loss was not reported.The patient is reported to have presented at the hospital where hemoglobin was found to have dropped.A blood transfusion was administered on the same day and the hemoglobin is reported to have increased.No additional information is available.

Manufacturer Narrative

The device was not evaluated on site by a qualified technician because this event is associated with a user (patient) error.Based on the information received by the nurse, the home patient did understand that they made a mistake.The home patient was re-trained after the incident.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.The ak96 operator's manual instructs the user about the correct connection of disposables to the machine."to avoid patient blood loss and blood hemolysis, it is important to follow the manufacturer¿s instructions for use of the dialyzer and the blood lines.When attaching the blood lines always ensure that all connections are properly secured and that no part of the blood lines have been kinked.If the heparin pump is not to be used, especially ensure that the cap at the end of the thin line used for heparin solution, is properly closed." "check all necessary clamps.If the heparin pump is not to be used, especially ensure that the cap at the end of the thin line used for heparin solution, is properly closed." 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: 12676023
• MDR Text Key: 282352628
• Report Number: 9616026-2021-00059
• 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
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 110661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WATER SYSTEM WRO 300
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR