HTP1500
Received Mar 4, 2022 · Event occurred Sep 20, 2021
Report 13666199 · MDR key 13666199
Device
Generic name
Pack, Hot Or Cold, Water Circulating
Manufacturer
Adroit Medical Systems, Inc.Model number
HTP1500Catalog number
HTP1500
Product problems
- Device Contamination with Chemical or Other Material
Patient
21900 DA · Female
- Unspecified Infection
- Multiple Organ Dysfunction Syndrome
- Unspecified Infection
- Multiple Organ Dysfunction Syndrome
Narrative
Description of Event or Problem
THE PATIENT HAD A DOUBLE LUNG TRANSPLANT PERFORMED IN (B)(6) LAST YEAR. THE PATIENT REQUIRED CIRCULATORY AND RESPIRATORY SUPPORT AND WAS PLACED ON ECMO DURING THE PROCEDURE. THE ECMO DEVICE WAS PAIRED WITH A DISPOSABLE WATER HEATER TO WARM THE ECMO CIRCUIT. THE PATIENT DEVELOPED A BLOOD STREAM AND LUNG INFECTION. THE BLOOD CULTURES WERE POSITIVE FOR RALSTONIA (BURKHOLDERIA) AND THE LUNG BAL CULTURES WERE POSITIVE FOR PSEUDOMONAS. THE PATIENT REMAINED CRITICALLY ILL, WAS NOT ABLE TO BE WEANED FROM ECMO, DEVELOPED MULTI-SYSTEM ORGAN FAILURE AND EXPIRED BY THE END OF (B)(6) LAST YEAR. THE DISPOSABLE WATER HEATER WAS CULTURED. THE CULTURES REVEALED RALSTONIA, PSEUDOMONAS AND CUPRIAVIDUS.