MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to #1828100-2015-00891.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the heater cooler unit would not power on.When the unit was turned on, all the lights started to blink, alarms sounded and the unit could not finish booting up.As a result, an alternate system was employed.There was no delay and no blood loss.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The feild service representative has been in contact with the user facility regarding timing for repairs.Investigation is ongoing.

Event Description

Additional information: the surgical procedure was completed successfully.There were nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) found that the unit required service confirming the complaint.He replaced the main computer card (printed circuit board assembly-pcba) as tested the unit for functionality.The unit passed release testing and was returned to clinical use.The fsr accidentally dropped the suspect part from his work surface onto the floor where it cracked the board.Therefore, the fsr disposed of the part and no part wil be returned for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5195462
• MDR Text Key: 30363090
• Report Number: 1828100-2015-00934
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2015; 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2002
• 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