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

Model Number 4415

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported issue was verified by the field service representative (fsr) on site.He troubleshoot the compressor using field service handbook and measured voltages on compressor delay printed circuit board (pcb).The device had a line voltage at p-66 which was not expected.As per fsr, troubleshooting led to bad compressor.The device was not returned to the manufacturer as the customer has taken the unit out of service.The customer scrapped the device.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 use of the device for a cardiopulmonary bypass (cpb) procedure, the heater cooler (tcm ii) was recycling through out the procedure and intermittently resetting.The unit was changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.As per clinical review on 06-feb-2017: as per certified clinical perfusionist (ccp), the tcm ii was re-set multiple times during the procedure.Re-set means the unit goes to standby (like it does on initial boot-up) which stops all pumps and heater functions.After the re-set was completed, the user can choose warming or cooling options.This re-setting, according to ccp, happened at least 3 times during the procedure.Once after initial priming of the tcm ii during preparation of the cpb circuit.Once just prior to the start of cpb, when the tcmii was being set and prepared for the start of cpb.Once during cpb, when rewarming of the water (to rewarm the patient) was initiated.As rewarming requires a consistent and steady rise in the water temperature, the tcm ii was changed out during this third re-set in order to prevent the potential for prolonged rewarming of the patient.The change out did not delay the procedure and the patient remained stable.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

• 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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6366437
• MDR Text Key: 68830864
• Report Number: 1828100-2017-00100
• 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
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• 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
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/1995
• 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