Tablo Hemodialysis System, Cartridge
Received Jul 28, 2026 · Event occurred Jun 28, 2026
Report 3010355846-2026-00075 · MDR key 50054005
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Outset Medical, Inc.Lot number
M25330104S01
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
It was reported that the arterial pod on the cartridge broke and got stuck on the Tablo during patient treatment. There was an estimate of 25-50 mL blood loss. No patient adverse event was noted as a result of this event.
Additional Manufacturer Narrative
Tablo instructions for use (IFU) warning and caution: Check all bloodlines for leaks after the treatment has started. Keep access sites uncovered and monitored. Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury, and death. Machine alarms may not occur in every blood loss situation.The cartridge was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined.A review of production records for this lot number did not note any related manufacturing nonconformances that would contribute to this event.