MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP HEATER COOLER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(M)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

Adult pt on ecmo with malfunctioning heater cooler.Pt was on day three of ecmo therapy.Set temperature was 37 degrees c.The heater cooler did not achieve set temperature.Heater cooler only reached temperatures of 36.5 - 36.8.The pt was removed from ecmo therapy on (b)(6) 2020 which was day eight of therapy.The pt remains critically ill on the ventilator.Fda safety report id# (b)(4).

• Brand Name: CARDIOQUIP HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP ; college station TX 77845
• MDR Report Key: 9632362
• MDR Text Key: 176669056
• Report Number: MW5092515
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR