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

Catalog Number 955606

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a home patient who was treated with an ak98 dialysis machine, performed therapy overnight.According to the reporter the following morning, the patient was found unresponsive while connected to the dialysis line and a code blue was called.The patient was transferred to the emergency department and was found to have air in circulatory system/air embolism.The patient required intubation, hyperbaric therapy, and was placed in intensive care unit.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the device was not received for evaluation; however, an event history log review was performed.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The machine operated as expected and no air entered the system during the treatment.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.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 MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16819787
• MDR Text Key: 314051996
• Report Number: 9616240-2023-00003
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124502
• UDI-Public: (01)07332414124502
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 955606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 06/07/2023
• Supplement Dates FDA Received: 06/01/2023; 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention