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

Model Number MCH- 1000 (M)

Device Problems Melted (1385); Smoking (1585); Defective Component (2292)

Patient Problems Hypothermia (1915); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Event Description

The device was set up for an ecmo procedure on a patient.Within 2 minutes of beginning the procedure, the or staff began to notice smoke emanating from the mch device.

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.A patient was involved during the malfunction of the device, no information was provided about patient outcome, but cardioquip was informed the patient was hypothermic after the device malfunctioned.During the investigation, cardioquip identified the heaters to be the source of the malfunction.The heaters distributed heat unevenly and caused the bushings to melt.Cardioquip also identified a external temperature controller and associated wiring to be nonfunctioning.All needed components were replaced and the device passed final inspection and is fully functional.

Event Description

Customer reports smoke coming from device during procedure.

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.A patient was involved during the malfunction of the device, no information was provided about patient outcome, but cardioquip was informed the patient was hypothermic after the device malfunctioned.During the investigation, cardioquip identified the heaters to be the source of the malfunction.The heaters distributed heat unevenly and caused the bushings to melt.Cardioquip also identified a external temperature controller and associated wiring to be nonfunctioning.All needed components were replaced and the device passed final inspection and is fully functional.

Event Description

Customer reports smoke coming from device during procedure.

• 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: 10094069
• MDR Text Key: 207360818
• Report Number: 3007899424-2020-00003
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH- 1000 (M)
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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 Age: 23 MO