MAUDE Adverse Event Report: ADROIT MEDICAL SYSTEMS, INC. HTP1500; PACK, HOT OR COLD, WATER CIRCULATING

Model Number HTP1500

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2020

Event Type  Death  

Event Description

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.

• Brand Name: HTP1500
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): ADROIT MEDICAL SYSTEMS, INC.; 1146 carding machine rd; loudon TN 37774
• MDR Report Key: 13666185
• MDR Text Key: 286563344
• Report Number: 13666185
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: HTP1500
• Device Catalogue Number: HTP1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 8395 DA
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Race: White