PRISMAFLEX SETS (ST)
Received Jul 31, 2026 · Event occurred Jun 15, 2026
Report 8010182-2026-00617 · MDR key 50100438
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955596
Lot number
25B0075CB
Product problems
- Break
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It is reported that during priming of a Prismaflex set, the intravenous jug broke and leaked. There was no patient involvement. No additional information is available.
Additional Manufacturer Narrative
Prismaflex ST150 set C has been temporarily approved for use in the US under Emergency Use Authorization EUA200704 to deliver CRRT to treat patients in an acute care environment during the COVID-19 pandemic. Should additional relevant information become available, a supplemental report will be submitted.
Remedial action
- Notification