MAUDE Adverse Event Report: CARDIOQUIP, LLC MCH-1000; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/05/2020

Event Type  Injury  

Event Description

Additional details for this patient: the patient was initially cannulated for ecmo after lung transplant.The patient was found to have positive blood and sputum cultures respectively for burkholderia.The patient was able to come off ecmo.The patient continues to be treated.Manufacturer response for heater/cooler, (b)(4) (per site reporter): no response to date.

Event Description

The infection control service noted an increase in burkholderia infections amongst patients on the cardiothoracic icu.Isolates were sent for genome sequence testing.Six of the patients had closely related sequences and a seventh had a potentially related sequence.All the patients were reviewed.A common trait amongst all was the use of ecmo for cardiopulmonary support.The ecmo devices were investigated.Ecmo devices have a pump component and a heater component.The heater is needed to maintain body temperature while the blood is outside the body.The heater has a water bath.The water in the bath is not in contact with blood from the patients but is present inside the patient's room.Water baths were cultured and found to have burkholderia.Some water baths also had a second organism called cupriavidus pauculus.All ecmo heater devices were taken out of service.The culture results suggest the source of the patients' infection may be the water heaters.Additional details for this patient: the patient was initially cannulated for ecmo after lung transplant.The patient was found to have positive blood and sputum cultures respectively for burkholderia.The patient was able to come off ecmo.The patient continues to be treated.Manufacturer response for heater/cooler, mch-1000 (per site reporter): no response to date.

• Brand Name: MCH-1000
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 11452954
• MDR Text Key: 238877270
• Report Number: 11452954
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23725 DA
• Patient Weight: 53