THERMAX BLOOD WARMER UNIT
Received Jul 14, 2026 · Event occurred Aug 31, 2025
Report 3003504604-2026-00005 · MDR key 25815762
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955515
Lot number
NA
Product problems
- Crack
Patient
NA · Unknown
- Dyspnea
- Low Blood Pressure/ Hypotension
- Hypervolemia
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 APPROXIMATELY 10-15 MINUTES AFTER STARTING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A THERMAX BLOOD WARMER UNIT, TWO ALARMS WERE TRIGGERED. IT WAS FURTHER REPORTED THAT THE BOTTOM OF THE DEVICE WAS CRACKED. CRRT WAS DISCONTINUED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. THE PATIENT BECAME HYPOTENSIVE WITH LOW HEMOGLOBIN AND FLUID OVERLOAD WITH RESPIRATORY DISTRESS. ACCORDING TO THE REPORTER THE PATIENT REQUIRED A PACKED RED BLOOD CELL TRANSFUSION. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.