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

Model Number MCH-1000(I)

Device Problems Contamination (1120); Insufficient Information (3190)

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

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

Bacterial contamination reported.

Event Description

Customer disconnected a (b)(6) connector from the quest mps without first valving, clamping, or disconnecting the valved connector from the mch.Water sprayed in the or, including on the patient.Customer says that water from the mch tested positive for "a few things" but has not communicated any specifics.Customer is using their own hoses, with no inline valves.Hoses, mps, and blanket were previously connected to a 3t and have not been simultaneously disinfected.

Event Description

Customer disconnected a hansen connector from the quest mps without first valving, clamping, or disconnecting the valved connector from the mch.Water sprayed in the or, including on the patient.Customer says that water from the mch tested positive for "a few things" but has not communicated any specifics.

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.It was reported by the customer that the device tested positive for a few things however they did not provide any further clarification as to what they meant by this.The operator failed to clamp or valve the line prior to disconnection.The primary cause was the use of flexible surgical tubing material instead of the cardioquip hose kits that were provided with the device.Surgical tubing should not be used for hcd water lines, as it creates a significant spray hazard every time it is pressurized.

• 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: 13518665
• MDR Text Key: 296311072
• Report Number: 3007899424-2022-00001
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2017
• 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