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

Model Number MCH-1000 (M)

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) hospital submitted a user facility report (b)(4).Cardioquip followed up with bwh to request the device be returned to cardioquip for investigation.(b)(6) requested the device be held for investigation by bwh's personnel and have cardioquip assist in disassembling the device.(b)(6) allowed cardioquip's personnel to come onsite and view the device.Cardioquip was not permitted to perform any form of verification or testing of the device to confirm involvement in the report.(b)(6) indicated they would perform testing of the device to determine contamination and the results of the testing would be supplied to cardioquip.(b)(6) provided a description of the results but did not provide the quantitative data that would allow for further investigation and evaluation of the event.Cardioquip continues to maintain dialogue with bwh regarding this event.

Event Description

Describe the event or problem: additional details for this patient: the patient was initially cannulated for ecmo after coronary valve replacement surgery.The patient was found to have positive blood and sputum cultures for burkholderia.The patient was able to come off ecmo.The patient continues to be treated.The associated user facility report is mdr (b)(4).

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.

Event Description

Manufacturer recieved user facility report from the fda.Patient was initally cannulated for ecmo after cornonary valve replacement surgery, found to have positive blood and sputum cultures for burkhodleria.

• 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: 11659597
• MDR Text Key: 247073739
• Report Number: 3007899424-2021-00003
• 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: 04/13/2021
• 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?: Yes
• Date Device Manufactured: 05/01/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White