PRISMAFLEX SET
Received Jul 7, 2026 · Event occurred Jun 8, 2026
Report 8010182-2026-00548 · MDR key 25735816
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
107142
Lot number
25J0080
Product problems
- Protective Measures Problem
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER APPROXIMATELY SIX (6) HOURS OF CONTINUOUS RENAL REPLACEMENT THERAPY WITH THREE (3) PRISMAFLEX HF1400 SETS, "RETURN PRESSURE" ALARMS WERE OBSERVED, "RESULTING IN THREE FAILURES OF RESTITUTION, INCLUDING TWO WITHIN LESS THAN 24 HOURS." THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER ADDRESS: (b)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Remedial action
- Notification