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

Model Number MCH-1000(M)

Device Problems Arcing (2583); Unintended Electrical Shock (4018)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the device, it was found that the heater wires had a tear in the insulation, that would under normal condition stop the direct contact with the heater wiring and side panel of the unit.(b)(4).

Event Description

Customer reports that the unit has high leakage and shocked a patient during the duration of the warming cycle causing fibrillation."the electroactivity in the ekg increase," the lim sensor went off, and the customer saw a "lightning bolt" symbol on the screen.Customer also reports that this is the first time the device has been used of a patient.

Event Description

Customer reports that the unit has high leakage and shocked a patient during the duration of the warming cycle causing fibrillation."the electroactivity in the ekg increased", the lim sensor went off, and the customer saw a "lightning bolt" symbol on the screen.

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 the heater assembly was nonfunctional.Following replacement, the device passed inspection, and is fully operational.

• 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: 10019669
• MDR Text Key: 189700788
• Report Number: 3007899424-2020-00002
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Device Lot Number: 11161242
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1