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 Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility, after the procedure they had the receptacle inspected and when the unit was plugged back in the red alarm light was not illuminated.The field service representative (fsr) verified the reported complaint.He found the unit to be drawing 223/222 amps.After unplugging on all alternating current (a/c) sources the unit was still drawing too much current.The power cord had a common wire measuring a 30.22 ohm reading.He replaced the power cord.The unit operated to the manufacturer's specifications.The suspect part will be returned to the manufacturer.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 had a red light illuminated on the isolation panel.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cpb procedure on (b)(6) 2018, the heater cooler was leaking current, therefore the over current message (red light) was notify the perfusionist on the isolation panel.This did not affect the function of the heater cooler and it was used throughout the case.The patient nor the user was affected by the leakage of current.The perfusionist pulled the machine out of service at the end of the procedure and the field service representative (fsr) exchanged the plug.There was no delay in the surgical procedure due to the issue.There was no harm or blood loss associated with the concern.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found that there was a low resistance between the common and ground wires of the power cord.Resistance was measuring at 11 ohms when infinite resistance was expected.There was also overheating observed on the plug end of the power cord.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

As per field service representative (fsr) there was an alarm sounding when the red light was illuminated but the user facility silenced the alarm.

• 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: 7601851
• MDR Text Key: 111164754
• Report Number: 1828100-2018-00311
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1