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

Catalog Number 115251

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a hemodialysis patient passed away during treatment with an ak 98 machine.The patient was connected to the device at the time of death.At an unknown time during treatment the medical staff noticed that the patient was unresponsive.No alarm was generated by the ak 98 dialysis machine prior to or as the patient became unresponsive.Cardio-pulmonary resuscitation was initiated, and the patient was transferred to the hospital and subsequently passed away.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated by the local engineer service.No defect or issue was found.Review of downloaded treatment data by the manufacturer showed that the treatment went on without issues until nine, when the arterial and venous pressures started being unstable and quickly increased causing the presence of persistent alarms.At the same time, the blood pressure monitor (bpm), revealed low blood pressure values as well as an accelerated heart frequency.The review confirm that no technical alarm was generated and all the function checks were passed prior to starting the treatment.There is no data indicating any malfunction of the ak 98 machine.The reported condition was not verified.It is unlikely that the ak 98 caused or contributed to the serious event of patient death.This is more likely associated with the underlying medical condition in a patient with an extensive cardiac history.Based on additional information received, the ak 98 machine was determined not to be a factor in the reported adverse event.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: 12287855
• MDR Text Key: 265388901
• Report Number: 9616026-2021-00043
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BICART CARTRIDGE; NOVALINE BL102 BLOODLINE; BICART CARTRIDGE; NOVALINE BL102 BLOODLINE
• Patient Outcome(s): Death