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 Patient Involvement (2645)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

The issue was discovered when the perfusionists were doing their normal cleaning and replacing of the fluid.As per the field service representative (fsr), it was verified that in heat mode, there was water trickling over the ice bank intermittently.He replaced the solenoid valve #1.The unit operated to manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during the use of the device for a non-clinical activity, the flow rate was not where it should be.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed there to be no external damage of the solenoid valve.It appears that only the upper portion of the valve, which includes the solenoid, was replaced in the field as the lower valve portion is clean in comparison to the upper portion.Coil resistance measured 95 ohms, which is typical.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: 7812461
• MDR Text Key: 118104991
• Report Number: 1828100-2018-00439
• 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
• Report Date: 09/24/2018

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: 08/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1