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

Model Number MCH-1000 (M)

Device Problem Microbial Contamination of Device (2303)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

Customer reports dirty internal tubing in device.

Manufacturer Narrative

The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since (b)(6) 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.Customer reports dirty internal tubing as a cause for possible poor patient outcomes.Investigation was performed by hospital and a discussion with cardioquip about the ifu cleaning procedure occurred, as cardioquip was not allowed access to the device.Upon interviewing the healthcare provider, the routine maintenance that is required (according to the ifu) was not performed adequately.

• 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: 14739193
• MDR Text Key: 301990265
• Report Number: 3007899424-2022-00010
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCH-1000 (M)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2014
• 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