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

Catalog Number 955404

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

Patient Problem Myocardial Infarction (1969)

Event Date 05/21/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with an ak 98 machine, a patient experienced a myocardial infarction and passed away.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

Correction: b4/f8: date of this report in follow-up mdr #1 is being corrected from blank to 07/21/2021.

Manufacturer Narrative

H10: a service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 12026987
• MDR Text Key: 257116031
• Report Number: 9616026-2021-00027
• 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,Followup
• Report Date: 07/21/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/21/2021
• Supplement Dates FDA Received: 07/21/2021; 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death