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 Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the heater cooler was not switching from the small tank to the large tank.No other details regarding the nature of this event were provided.

Manufacturer Narrative

The manufacturer's technical support specialist verified the reported complaint.Valve five was found to be frozen so he replaced it.He also replaced valve four as a precaution.The unit operated to the manufacturer's specifications.The suspect parts were returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the inside of the valve contained a large amount of corrosion preventing it from operating correctly.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: 7927008
• MDR Text Key: 122458135
• Report Number: 1828100-2018-00503
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 11/30/2018
• Supplement Dates FDA Received: 11/20/2018; 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1