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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 Device Alarm System (1012)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Per the biomed: they defrost the cooler heater unit once a year during preventive maintenance (pm), the fault indicator light was illuminated for "will not prime", their maintenance process for the unit is they clean condenser fins and filter, oil check functions yearly, their chlorine maintenance schedule is yearly, and use 1 cup of chlorine, no leaks were observed, the water was not cloudy or discolored and there is no knowledge of patient infection that may be associated with the cooler heater unit.

 
Event Description

The user facility铠biomedical engineer (biomed) reported that during routine testing of the device, she found the cooler heater unit in a constant alarm. There was no patient involvement.

 
Manufacturer Narrative

(b)(4). The reported complaint was confirmed. The field service representative (fsr) verified the reported issue, the cooler heater unit had very sludgy water in the tank and was constantly alarming "pump not primed". The fsr drained the tank, cleaned and flushed the water, removed the pressure sensor and removed debris that was blocking the fitting. The fsr drained and cleaned the tank again, reinstalled the pressure sensor and tested for function. The unit operated to manufacturer's specification and was returned to clinical use. 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 Key5596603
MDR Text Key44024797
Report Number1828100-2016-00272
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 BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 06/20/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2016
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/29/2006
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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