inforMED
DeathILO

HTP1500

Received Mar 4, 2022 · Event occurred Dec 17, 2020

Report 13666185 · MDR key 13666185

Device

Generic name

Pack, Hot Or Cold, Water Circulating

Model number

HTP1500

Catalog number

HTP1500

Product problems

  • Device Contamination with Chemical or Other Material

Patient

8395 DA · Female

  • Unspecified Infection
  • Unspecified Infection

Narrative

Description of Event or Problem

THE PATIENT UNDERWENT ECMO PLACEMENT FOR CIRCULATORY SUPPORT AFTER BEING ADMITTED IN CRITICALLY ILL CONDITION IN (B)(6) 2020. THE ECMO DEVICE WAS PAIRED WITH A DISPOSABLE WATER HEATER TO WARM THE ECMO CIRCUIT. THE PATIENT REMAINED ON ECMO FOR HER ENTIRE HOSPITAL COURSE FROM (B)(6) 2020 THROUGH (B)(6) 2022. THE PATIENT EVENTUALLY UNDERWENT LUNG AND KIDNEY TRANSPLANTS IN (B)(6) 2021. THE PATIENT DEVELOPED INFECTION IN HER LUNGS WITH CUPRIAVIDUS. THE WATER HEATER WAS CULTURED IN (B)(6) 2021 WHICH REVEALED RALSTONIA, PSEUDOMONAS, CUPRIAVIDUS AND SPHINGOMONAS. DESPITE AGGRESSIVE TREATMENT, THE PATIENT EXPIRED IN (B)(6) 2022.