MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 98; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955604

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with an ak 98 device, the patient mistakenly programmed the ak 98 to remove 6.1l of fluid instead of the intended 1.6l during the two hours of treatment.The ultrafiltration (uf) rate per hour was 3.0l per hour instead of 800ml per hour.Approximately 45 minutes into treatment, the patient presented with blood pressure drop (value not provided).The ultrafiltration was stopped and an unknown amount of 0.9% normal saline was administered.No additional information is available.

Manufacturer Narrative

H10: the event history log files were returned and analyzed, and it was determined that the operator wrongly set the uf volume (6.1 l instead of 1.6), causing an excessive uf rate.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the reported condition was a user error.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 98
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12080529
• MDR Text Key: 262966428
• Report Number: 9616240-2021-00002
• 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: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.9% NORMAL SALINE
• Patient Outcome(s): Required Intervention