MAUDE Adverse Event Report: CARDIOQUIP, LLC CARDIOQUIP MODULAR COOLER-HEATER (MCH); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/17/2021

Event Type  malfunction  

Event Description

A report was received of a badly burned electrical outlet in the operating room equipment storage room.Operating room staff was requested to search for any device that might have a similarly burned condition.Within a few minutes a cardioquip heater-cooler, model mch1000i, was found with a severely melted and charred ac plug.The damage apparently occurred sometime during the previous day or night.Inspection of the ac power plug identified solder-tinned conductors clamped in the terminal blades.A search was made of other cardioquip heater-coolers to inspect their ac plugs.Of three more units found, two had solder-tinned conductors in the plug.One of these showed evidence of overheating to the point of melting the plug body, but it had not progressed to the point of discoloration.These two solder-tinned power cords were cut back and re-attached to good plugs without tinning.Two more cardioquip units remain to be retrieved and inspected.I sent an email notification to the manufacturer informing them of our discovery and expressing concern about the use of solder-tinned wires within clamped wire connections.I received a quoted statement in return implying that terminal connections within a power cord are normally tightened periodically when the manufacturer performs scheduled maintenance, which they have not been asked to do for our devices.Our htm technicians perform scheduled maintenance according to the manufacturer's written guidelines, which do not mention disassembling and tightening the ac power plug connections.Manufacturer response for patient heater-cooler, cardioquip (per site reporter): a senior engineer was quoted in an email reply by other mfr staff saying "it is a known behavior of screw-clamp plugs that they must be tightened regularly, as specified by their manufacturer, to ensure a good connection.This is part of the annual preventive maintenance procedure performed by cardioquip service technicians; unfortunately, this unit has not been serviced by cardioquip in two years.".

• Brand Name: CARDIOQUIP MODULAR COOLER-HEATER (MCH)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 12655841
• MDR Text Key: 277114989
• Report Number: 12655841
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/14/2021,10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000(I)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1