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 Unspecified Infection (1930)

Event Date 02/09/2021

Event Type  Injury  

Event Description

Additional details for this patient: the patient was initially cannulated for ecmo after cardiac surgery.The patient was found to have positive sputum cultures for burkholderia.The patient was able to come off ecmo.The patient was discharged to rehab hospital.Manufacturer response for heater/cooler, mch-1000 (per site reporter): no response to date.

Manufacturer Narrative

The incident unit has been requested but to date has not been received for evaluation.If the unit is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

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 for respiratory failure related to covid infection.The patient was found to have positive sputum cultures 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: 11452855
• MDR Text Key: 238875938
• Report Number: 11452855
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24090 DA
• Patient Weight: 71