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 Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per field service representative (fsr), the user facility has taken the unit out of service.This complaint is related to (b)(4)/ medwatch #1828100-2018-00145.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the water flow was low.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.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) verified the reported issue.He replaced valves two, three and the main pump assembly.The reported issue remained.As per fsr, the replaced parts were disposed of and the unit was taken out of service.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

The field service representative (fsr) was unable to duplicate the complaint.He verified the unit had good flow over the cold plate.The unit operated to the manufacturer's specifications.

Event Description

Additional information received indicated that the event happened during set-up for a cardiopulmonary bypass (cpb) procedure.Per clinical review: during set-up for a cpb procedure on (b)(6) 2018, it was noticed by the team that the unit had low water flow and insufficient warming.The team opted to changed out the unit for a fully functioning one before the surgery started.The incident with the heater cooler did not delay the start of the surgical procedure.There was no blood loss or harm associated with the event, for the unit was not used on the procedure.

• 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: 7361505
• MDR Text Key: 103429859
• Report Number: 1828100-2018-00146
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1