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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 Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Per the user facility¿s biomedical engineer ((b)(4)): he does not have any knowledge of patient infection that may be associated with the cooler heater unit, and a third party ((b)(4)) currently performs preventive maintenance (pms).

 
Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there were fragments/debris found in the tank of the cooler heater unit (black rubber possibly, not fungus). 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 not verifiable. The customer has not responded to inquiries for service or respond for follow up information and no parts have been returned for evaluation. This customer uses a third party for preventive maintenance (pm) service. The manufacturer provides established requirements for sanitization and instructions for correctly maintaining the system. These are clearly outlined in the operators manual. Included in the requirements is a daily sanitization procedure with a check of the chlorine levels, weekly cleaning and sanitization and a semiannual descaling procedure. Decontamination is required whenever biofilm is evident in the system. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
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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 Key5797778
MDR Text Key50388590
Report Number1828100-2016-00505
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/15/2016
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 Received09/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/25/2006
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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