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

Model Number MCH-1000(M)

Device Problem Excessive Heating (4030)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is pending.Suspect device has yet to be made available to cardioquip for evaluation.

Event Description

Customer reports that the unit is giving high temp alarms after running for 5-7 hours while on a patient, with users reporting that they've seen the delivery temperature spike to over 55 degrees at one point.

Manufacturer Narrative

Upon receiving the device, an inspection of the wiring found that a wire at terminal a1 of the dc voltage connecion for the pump control board assembly was loose.The customers description of the event was able to be replicated, by setting the device to "run" with the pump unplugged and set at 37ºc.The pump was reconnected, afterwhich there was a spike in temperature for about 3 seconds.The devices loose wire at the pump control board allowed a section of hot water to accumulate at the heater chamber and upon receiving enough voltage, to run, the pump then sent the hot water from the heater chamber throughout the water circuit until it cooled back to the set point.Concluding that the loose wire at terminal a1 of the pump control board caused the event the customer described.After properly reseating the wire, the device passed a full inspection.The cause of the improperly unseated wire is unknown.A cardioquip certified inspection has not been performed on the device since its manufacture, in (b)(6) 2018.A1-a6 no patient information provided by the user facility.

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 customer notified cardioquip, that a patient was involved during the malfunction although no patient information was communicated.Cardioquip's investigation determined that a wire on the pump control board was loose.Following the repair, the device passed inspection, and is fully operational.

Event Description

Customer reports that the unit is giving high temp alarms after running for 5-7 hours while on a patient, with users reporting that they've seen the delivery temperature spike to over 55 degrees at one point.

• 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: 10291910
• MDR Text Key: 201730300
• Report Number: 3007899424-2020-00006
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: No
• 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: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1