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

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 02/17/2021

Event Type  Death  

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 steps taken or underway include: review of all positive cultures from all ecmo patients from the past year to identify any others with burkholderia or cupriavidus infections.Review of all hospitalized patients with burkholderia or cupriavidus infections in the past year to identify any non-ecmo patients that may have been involved.Subspeciation of all burkholderia isolates from the past year to identify if any were of the same spaces as the cluster strain ("burkholderia contaminans").Bioaerosol sampling adjacent to an operational ecmo water heater to look for aerosolization of burkholderia and/or cupriavidus.Cultures of water, faucet, and drain in the ecmo heater cleaning area.Ecmo water heater burkholderia and cupriavidus specimens are being sent for whole genome sequencing to see if they match patients' isolates.Ecmo water heaters will be put through their current disinfection cycle and then recultured to assess the adequacy of the process.

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 had a tavr (transcatheter aortic valve replacement).Patient went on ecmo by mid-december.Had a right heart assist device (rvad) implanted and went off ecmo for about a week.Then, patient went back to ecmo.The patient was found to have positive blood and sputum cultures for burkholderia.The patient continued to deteriorate despite maximal cardiopulmonary support and expired by the end of january.Additional steps taken or underway include: review of all positive cultures from all ecmo patients from the past year to identify any others with burkholderia or cupriavidus infections.Review of all hospitalized patients with burkholderia or cupriavidus infections in the past year to identify any non-ecmo patients that may have been involved.Subspeciation of all burkholderia isolates from the past year to identify if any were of the same spaces as the cluster strain ("burkholderia contaminans").Bioaerosol sampling adjacent to an operational ecmo water heater to look for aerosolization of burkholderia and/or cupriavidus.Cultures of water, faucet, and drain in the ecmo heater cleaning area.Ecmo water heater burkholderia and cupriavidus specimens are being sent for whole genome sequencing to see if they match patients' isolates.Ecmo water heaters will be put through their current disinfection cycle and then recultured to assess the adequacy of the process.

• 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: 11453018
• MDR Text Key: 238851014
• Report Number: 11453018
• 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: 02/26/2021

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: 02/26/2021
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 28470 DA
• Patient Weight: 102