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 4416

Device Problem Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per technical support, this failure mode would reduce cold water supply to the cardioplegia outlets and this could impact the ability to cool cardioplegia solution.

Event Description

It was reported that during the use of the device for a non-clinical activity, the solenoid valve v4 of cardioplegia line chattered continuously when the user switched on the machine (main circuit breaker cb1).The user switched to v5 input and it started to chatter.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per the manufacturer's subsidiary, no parts will be returned for evaluation.The part is with the user facility and it was repaired locally.The customer replaced the 1/2 inch solenoid valve to resolve the reported problem per the manufacturer's technical support representative.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6507166
• MDR Text Key: 73505531
• Report Number: 1828100-2017-00193
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4416
• Device Catalogue Number: 4416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2008
• 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