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 Problems False Alarm (1013); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.Manufacturer technical support troubleshooting provided the following solution with the biomed.The biomed reseated the computer card and the reported issue was resolved.The unit was returned to clinical use.Per the biomed: they do their own maintenance every three months, the water was not cloudy or discolored and he had no knowledge of patient infection associated with the cooler heater.No parts will be returned to the manufacturer 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.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the light emitting diode (led) lights did not come on main display when started.Start-up alarm worked as it should.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: 5590452
• MDR Text Key: 43794578
• Report Number: 1828100-2016-00262
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/1997
• 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