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

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303)

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

Event Date 04/14/2021

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 spotted tubing is a result from lankenau medical center's contaminated water system.The spotted tubing was sent to cardioquip from lankenau medical center, for testing.A swab sample was taken of the tubing and found 200 cfu/swab of m.Franklinii.Cardioquip conducted testing at lankenau medical center and sampled various devices, source water, ice machine, and coolers.The lab reports indicated the same mycobacterium, m.Franklinii, was also found to be a contaminant within their source water, in which they used to fill up their heater-coolers.The spotted tubing was used on device serial number (b)(4) and that device also tested positive for m.Franklinii.

Event Description

Customer reports that the antimicrobial tubing of their heater coolers has developed dark spots or blotches, and they are very confused as to why this is occurring.The customer says they use bleach as a primary disinfectant, perform cleanings at least quarterly and that their facility uses water which has passed through a 0.2 micron filter.

• 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: 14739191
• MDR Text Key: 300074247
• Report Number: 3007899424-2022-00012
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2018
• 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