PRISMAX MACHINES
Received Jul 17, 2026 · Event occurred Jun 24, 2026
Report 9616240-2026-00025 · MDR key 25856752
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955725
Lot number
NA
Product problems
- Device Alarm System
- No Visual Prompts/Feedback
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY WITH A PRISMAX MACHINE, A CALL SERVICE ALARM (SYSTEM FAILURE) WAS TRIGGERED. THE MACHINE WAS REBOOTED, HOWEVER THE SCREEN BECAME UNRESPONSIVE AND TREATMENT COULD NOT BE RESUMED. AFTER RESTARTING TREATMENT WITH A NEW SET, THE SCREEN BECAME UNRESPONSIVE AGAIN. ON BOTH OCCASIONS, THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. AFTER A REPORTED CUMULATIVE BLOOD LOSS OF APPROXIMATELY 500ML, THE PATIENT BECAME "PROFOUNDLY" HYPOTENSIVE, WITH AN ESTIMATED MEAN ARTERIAL PRESSURE OF 40MMHG. THE PATIENT WAS TREATED WITH A METARAMINOL INFUSION AND ADDITIONAL BOLUSES. ADEQUATE BLOOD PRESSURE COULD NOT BE MAINTAINED, AND THE PATIENT WAS TRANSITIONED TO A DOUBLE-STRENGTH NORADRENALINE INFUSION. NO ADDITIONAL INFORMATION IS AVAILABLE.