MAUDE Adverse Event Report: CARDIOQUIP CARDIOQUIP HEATER COOLER DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000 MCH-1000(I)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Based on the guidance received from the fda letter to healthcare provider, "potential risk of infection during cardiac surgery when using the cardioquip modular cooler-heater device" dated september 30th 2020 and device concerns raised in the letter, we are submitting a voluntary report.On (b)(6) 2023, (b)(6) medical center clinical engineering and perioperative staff identified a failure to follow all manufacturer's instructions for use (mifus) for the cardioquip heater/cooler devices.The machines were removed immediately from use and sequestered while the machines were evaluated for contamination by the manufacturer by heterotrophic plate count (micro culture).One of three machines was found to have microbial growth; all machines underwent full annual preventive maintenance and sanitation with manufacturer's approved disinfectant.The contaminated machine was sent to the manufacturer for rehabilitation.Gaps identified included: quarterly inspection of internal components missed (new mifu requirement as of july 2021) and the wrong sized source water filter used to fill and disinfect the machines (0.2 micron required; 1.0 micron installed at the tap).A review of patient charts undergoing procedures in which the device was used found no infections.Surveillance for surgical site infections will continue for [1 year] following the last date the equipment was used prior to discovery of the gaps.As a result of the learnings from (b)(6) medical center, two additional hospitals within the (b)(6) health system who also use cardioquip heater/cooler devices did an extensive gap analysis between practice and mifus.Each discovered some variance from mifu.At (b)(6) medical center, the filtered water used for disinfecting the machines was found to have an expired filter (expired in january, 2023), and the annual preventive maintenance was performed by a contractor, rather than the manufacturer, as specified in the mifus.The filter was changed and all machines were taken out of service and sanitized after a careful inspection of the interior components.At (b)(6) medical center, the gap analysis found the machines to be currently compliant, but between january, 2022 and november, 2022 the machines were noted to have discolored tubing and microbial growth.We have included all the serial numbers but for additional clarity: smmc: (b)(6)(no contamination identified, just process failures noted).Reference report #mw5146816, #mw5146817, #mw5146818, #mw5146819, #mw5146820, #mw5146821, #mw5146822, #mw5146823.

• Brand Name: CARDIOQUIP HEATER COOLER DEVICE
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP; college station TX 77845
• MDR Report Key: 17920989
• MDR Text Key: 325814132
• Report Number: MW5146815
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000 MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 149 YR