FDA Adverse Event
Death
Summary report: N
AK 98 MACHINE
MDR report key: 25209268
·
Received May 18, 2026
Report
- Report Number
- 9616026-2026-00074
- Event Type
- Death
- Date Received
- May 18, 2026
- Date of Event
- April 13, 2026
- Report Date
- May 18, 2026
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Product Code
- KDI
- UDI-DI
- 07332414122973
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT A HOME PATIENT PASSED AWAY DURING HEMODIALYSIS ON AN AK 98 MACHINE. THE CAUSE OF DEATH IS "UNDETERMINED" AT THIS TIME BUT IS PENDING RESULTS FROM THE CORONER. THE REPORTER STATED THAT THE HOME PATIENT STARTED DIALYSIS TREATMENT APPROXIMATELY AT 12.00PM AND PASSED AWAY "SOMEWHERE BETWEEN 1400 AND 1500 HRS". NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606180 | AK 98 MACHINE | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | VANTIVE US HEALTHCARE LLC | NA | N/A | 07332414122973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death | NI. |