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

Model Number MCH-1000(M)

Device Problem Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

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.Upon inspection of the device, cardioquip identified the heater to have failed due to inadequate protection on the wires.This caused the component to short and melt the pvc on the heater chamber.All nonfunctioning components were replaced and the device passed final inspection and is fully funcitonal.

Event Description

Customer reports that the unit produced a "burning" smell and they found that the bushing of the 1600w heater had touched and started melting the plastic sheet used to protect the side panel of the mch-1000 from exposed wires.

Event Description

Customer reports that the unit produced a "burning" smell and they found that the bushing of the 1600w heater had touched and started melting the plastic sheet used to protect the side panel of the mch-1000 from exposed wires.

Manufacturer Narrative

Further review determined that this is a non-reportable event.

• 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: 15027327
• MDR Text Key: 304792528
• Report Number: 3007899424-2022-00066
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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