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

Model Number MCH-1000(I)

Device Problems Fluid/Blood Leak (1250); Smoking (1585); Microbial Contamination of Device (2303)

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

Event Date 07/30/2021

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.The device was found to be contaminated with m.Abscessus (50 cfu/ml).However, the customer has ceased communication and an initial investigation was not possible due to the lack of access to the device.

Event Description

Customer sent water samples to an independent lab to find out what they would culture.After receiving the lab results back, it was determined that the device was contaminated with m.Abscessus (50 cfu/ml).

Event Description

Customer reports that their device started producing smoke and leaking during a case.

Manufacturer Narrative

Cardioquip's investigation determined that the device was operated without water in the tank.The damaged components were replaced; 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: 14755155
• MDR Text Key: 294586451
• Report Number: 3007899424-2022-00025
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG