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 02/10/2021

Event Type  Injury  

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

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

Event Description

A patient was found to have positive sputum cultures for burkholderia after cardiac surgery.

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: 11667520
• MDR Text Key: 245495747
• Report Number: 3007899424-2021-00009
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• 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?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White