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

Model Number MCH-1000 (M)

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 12/16/2020

Event Type  Death  

Manufacturer Narrative

(b)(6) submitted a user facility report (b)(4).Cardioquip followed up with (b)(6) to request the device be returned to cardioquip for investigation.(b)(6) 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 (b)(6) have not been supplied to cardioquip.Cardioquip is in continuous dialogue with (b)(6) regarding their investigation and potential for the device to be returned to cardioquip at a later date.

Event Description

The patient was initially cannulated for ecmo for acute on chronic hypoxemic respiratory failure related to her copd and idiopathic pulmonary fibrosis.The patient was found to have positive blood and sputum cultures for burkholderia.The patient continued to deteriorate despite maximal cardiopulmonary support and expired.The associated user facility report is mdr (b)(4).

Event Description

Manufacturer recieved a user facility report from the fda.The patient was cannulated for ecmo for repiratory failure and pulmonary fibrosis.Patient found to have positive blood and sputum cultures for burkholderia.Deteriorated and died.

Manufacturer Narrative

The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The device was found to be contaminated with the same bacteria that caused infection in the patient (burkholderia).Due to lack of access to the device, an investigation on other similar devices at the location had to be performed.The test can conclude that all of the units would be contaminated but unable to decide on whether or not the device caused the adverse event due to the limitations of the investigation performed at the facility, cardioquip is also unable to rule out the possibility of a unified source of contamination for both the heater cooler and the patient, for example, a contaminated water source.

• Brand Name: CARDIOQUIP MODULAR COOLER HEATER
• Type of Device: CARDIOPULMONARY BYPASS DEVICE
• 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 Key: 11667556
• MDR Text Key: 245491090
• Report Number: 3007899424-2021-00007
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000 (M)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White