THERMAX BLOOD WARMER UNIT
Received Jul 21, 2026 · Event occurred Jun 20, 2026
Report 3003504604-2026-00006 · MDR key 25890971
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
- Insufficient Heating
Patient
Not reported
- Hypothermia
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY, USING A THERMAX BLOOD WARMER AND PRISMAX MACHINE. IT WAS FURTHER REPORTED THAT THE THERMAX DEVICE DID NOT INCREASE THE TEMPERATURE ABOVE 36 °C., AND THE PATIENT EXPERIENCED HYPOTHERMIA (NO TEMPERATURE READINGS WERE REPORTED). THE NURSING STAFF REPORTED THAT A THERMAX DISPOSABLE COLLAPSED ALARM WAS GENERATED AND THE THERMAX ¿WOULD NOT HEAT¿ (WAS SET TO 36.5 °C). ADDITIONALLY, THE THERMAX COVER OPEN ALARM WAS GENERATED AND COULD NOT BE CLEARED. TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. ACCORDING TO THE REPORTER, THE PATIENT¿S HEMOGLOBIN WAS ALREADY LOW, AND A BLOOD TRANSFUSION WAS REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.