MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO TCM II COOLING AND HEATING SYSTEM

Model Number 4415

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was a power failure to the front control panel of the cooler heater unit.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Customer has new biomedical group starting and they will check device before calling in for service.At this time, the customer is just reporting failure.Per the field service resp (fsr), the unit initially powered up to specification and ran all modes of operation with no indication of failure.The unit was powered down and up four or five times without fail.On the sixth or seventh time, the unit failed to go through its normal power up routine and the control panel would indicate no power and failure.After the power failure to the control panel, the fsr found that by resetting the printed circuit (pc) boards in the card rack, the unit would power on to normal state and all modes of operation worked correctly.The fsr proceeded to turn the unit off and on a half dozen times without further incident.The fsr performed preventive maintenance (pm), completed calibration and release test.The unit operated to mfr specifications and was returned to clinical use.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO TCM II COOLING AND HEATING SYSTEM
• Type of Device: TCM II COOLING AND HEATING SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4563889
• MDR Text Key: 20788828
• Report Number: 1828100-2015-00124
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2002
• 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