MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

Model Number 4415

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As per manufacturer's technical support specialist, the unit has reached its end of service life and cannot be repaired by the manufacturer.Per the manufacturer's subsidiary, the user facility's clinical engineer found the pressure sensor to be bad.After replacing the sensor the reported issue was resolved.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit stopped with an alarm and indicates low water although the water is at the maximum fill line.There was an approximately three hour delay.The surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the patient.Per clinical review: during set-up for a cpb procedure, the heater cooler gave the clinician an alarm and indicator that the water level was low.The water was at the maximum level in the unit.This error message was due to a pressure sensor failure in the system and will not enable water flow.The procedure was delayed approximately three hours while the biomedical technician was able to repair the issue.The surgical procedure with the repaired heater cooler proceeded without issue.There was no blood loss associated with the event.

Manufacturer Narrative

The reported complaint was confirmed.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 TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8288465
• MDR Text Key: 134463197
• Report Number: 1828100-2019-00047
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1