AK 98 MACHINES
Received Jul 7, 2026 · Event occurred Jun 5, 2026
Report 9616026-2026-00091 · MDR key 25736737
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
115251
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Dyspnea
- Hemolysis
- Nausea
- Vomiting
- Abdominal Cramps
Narrative
Description of Event or Problem
IT WAS REPORTED THAT 3 HOURS AND 45 MINUTES AFTER DIALYSIS WAS INITIATED USING AN AK 98 MACHINE, A HOME PATIENT EXPERIENCED HEMOLYSIS DUE TO A KINK ON THE ARTERIAL BLOOD LINE ABOVE THE DIALYZER. THERE WERE NO ALARMS REPORTED. THE PATIENT PRESENTED WITH CHEST/ ABDOMINAL CRAMPS, NAUSEA, VOMITING AND DYSPNEA. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS "A SIGNIFICANT DECREASE IN THE HEMOGLOBIN". THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE. IT WAS REPORTED THAT THE PATIENT WAS "RETRANSFUSED". NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.