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 Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the user facility's biomedical engineer (biomed) that the power was out to the cooler heater unit.No other details regarding the nature of this event were provided.

Manufacturer Narrative

(b)(4).Per follow-up with the user facility¿s biomedical engineer (biomed) on 17-may-2016: the biomed had no knowledge of patient infection that may be associated with the cooler heater unit; the ice block is defrosted after each case; there was no fault indicator lights illuminated; and the water was not cloudy or discolored.The reported issue was confirmed.The field service representative (fsr) verified the unit had no power, unit would not start up.After the fsr tested the unit he found that the hospital installed outlet plug had a loose connection creating an open circuit and no power to the unit.The fsr reinstalled the plug connection and tested the unit.The unit operated to manufacturer specifications and was returned to clinical use.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Updated information: the reported issue occurred during set-up of the device for a cardiopulmonary bypass procedure.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.

• 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: 5651097
• MDR Text Key: 45199146
• Report Number: 1828100-2016-00335
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• 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: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1