MAUDE Adverse Event Report: CARDIOQUIP, LP MCH-1000; CONTROLLER, TEMPERATURE

Model Number MCH-1000(I)

Device Problems Component Incompatible (1108); Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/27/2017

Event Type  No Answer Provided  

Event Description

At the end of cpb procedure, the perfusionist disconnected a non-valved water line connector between the hcd (a cardioquip mch-1000) and the quest mps without first clamping, valving, or disconnecting the valved connector at the opposite end of the water line.Water then sprayed across the operating room, hitting several people including the pt.The hospital is (b)(6).Cardioquip sent techs to the hospital to verify that the hcd was functioning properly (it was), and to further discuss the spray event with hospital personnel.We also communicated via telephone and email with the hospital's biomed tech, and the cardioquip distributor rep.Our investigation found: the primary cause of the spray event was the use of flexible surgical tubing for hcd water lines, instead of the cardioquip hose kits that were provided with the hcd, or even any other type of tubing commonly used with hcds.Surgical tubing is a very poor choice for hcd water lines, as it creates a significant spray hazard every time it is pressurized (something like a water balloon), and we know of no other facility that uses this type of tubing.According to hospital personnel, the surgical tubing is used on the insistence of the surgeon, against the advice of support personnel.A secondary cause of the spray event was operator error, as the perfusionist should not have disconnected a live water line without first clamping or valving; however, cardioquip believes that the surgical tubing would likely have caused a spray event regardless.The hospital does not simultaneously disinfect all of the device that comprise the hcd water path (the mch, quest mps, all tubing, pt blankets, etc.) this allows the devices to cross-contaminate each other's water.Thus, it is impossible to determine the origin of whatever microbes may have been found in the hcd water cardioquip is working with our customer in an attempt to help them address these issues.

• Brand Name: MCH-1000
• Type of Device: CONTROLLER, TEMPERATURE
• Manufacturer (Section D): CARDIOQUIP, LP; bryan TX 77801
• MDR Report Key: 6381133
• MDR Text Key: 69176987
• Report Number: MW5068288
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1