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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problems Device Contamination with Chemical or Other Material (2944); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem No Patient Involvement (2645)
Event Date 04/15/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(46). This complaint is related to emdr #1828100-2016-00436. The reported complaint was confirmed. The descaling agent is still available from the manufacturer. This information was passed on to the customer and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis. Review shows this unit has not been on a regular pm schedule since 2012. (b)(4).

 
Event Description

The customer reported that during preventive maintenance (pm) of the cooler heater unit, the device contained mineral debris in tank and feels it is because he cannot obtain the proper chemical for cleaning the units. There was no patient involvement. Per clinical review: on april 12, 2016 clinical services (cs) spoke to the perfusionist ((b)(4)) in regards to this issue. The field service representative (fsr) visited this hospital in past week and this customer complained of particulate being in this unit and that he was concerned with the particulate affecting heat exchange performance due to low water flow. He commented to the fsr, he was not able to get the chemicals to keep the unit clean. After my discussion with the (b)(4), he was told by his hospital biomed that the descaling agent (b)(6)) was no longer available for purchase. Cs checked with technical support and b)(6) is still available from the manufacturer. Cs passed this information on to the (b)(4) and he will work with his hospital biomed department to order the chemical so that descaling can be done and can continue to be done on a regular basis. In review of our records, this unit has not been on a regular preventive maintenance (pm) schedule since 2012 and this could be part of the issue. This complaint is based on concern for loss of function and was mentioned during a pm, not during a case.

 
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Brand NameSARNS TCM II HEATING AND COOLING SYSTEM
Type of DeviceCONTROLLER, 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
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5721043
MDR Text Key48159509
Report Number1828100-2016-00437
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4415
Device Catalogue Number4415
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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