• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION AK 96 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAK 96
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12676023
MDR Text Key282352628
Report Number9616026-2021-00059
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
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 Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number110661
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
Treatment
WATER SYSTEM WRO 300
-
-