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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER CARDIOPULMONARY BYPASS COOLER HEATER

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CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER CARDIOPULMONARY BYPASS COOLER HEATER Back to Search Results
Model Number MCH-1000(M)
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 02/17/2021
Event Type  Death  
Manufacturer Narrative

(b)(6) hospital (bwh) submitted a user facility report (b)(4). Cardioquip followed up with bwh to request the device be returned to cardioquip for investigation. Bwh did allow cardioquip's personnel to come onsite but personnel were not given access to the device. Additionally, at the time of this report, the device has not been returned to cardioquip for investigation and any results from testing performed on the device by bwh have not been supplied to cardioquip. Cardioquip is in continuous dialogue with bwh regarding their investigation and potential for the device to be returned to cardioquip at a later date.

 
Event Description

Describe the event or problem: 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 other[?][?] 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. The associated user facility report is mdr (b)(4).

 
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Brand NameCARDIOQUIP MODULAR COOLER-HEATER
Type of DeviceCARDIOPULMONARY BYPASS COOLER HEATER
Manufacturer (Section D)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer (Section G)
CARDIOQUIP, LLC
8422 calibration ct.
college station TX 77845
Manufacturer Contact
charley ford
8422 calibration ct.
college station, TX 77845
9796910202
MDR Report Key11667483
MDR Text Key245488587
Report Number3007899424-2021-00004
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 04/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMCH-1000(M)
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/30/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/14/2021 Patient Sequence Number: 1
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