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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 Microbial Contamination of Device (2303)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Per the biomed: i wanted to let someone know that one of our cooler heater units (this one coincidently) came back positive for ntm chimaera. We do not have any associated infections of this type and no connection to this cooler heater. This unit is currently not going to be utilized in patient care until we get the results back from a repeat test and only then if it is negative. We follow/exceed recommended cleaning procedures.

 
Event Description

It was reported that during the use of the device for a non-clinical activity, the cooler heater unit came back positive for nontuberculous mycobacteria (ntm) chimaera. There was no patient involvement.

 
Manufacturer Narrative

The reported complaint was not confirmed. On 04-may-2016, clinical services received follow up from the perfusionist (ccp). The repeat culture of water in the heater/cooler came back negative for nontuberculous mycobacteria (ntm) chimaera bacteria. The unit will be placed back in clinical service. The user facility has elected to culture their three heater/cooler units periodically to check for the presence of ntm bacteria. No patient has been diagnosed with an ntm infection. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
Manufacturer Narrative

 
Event Description

Per the clinical review on 31-mar-2016: the manufacturer's clinical services (cs) spoke to the user facility perfusionist (ccp) on (b)(6) 2016 in regards to this issue. (b)(4) cs asked the ccp to describe their routine practice for cleaning and disinfection of their cooler heater units. (b)(4). According to the ccp, this unit has been used regularly in clinical service (not stored for long periods) prior to the (b)(6) culture test. After the first (b)(6) culture test, the unit was drained and re-filled with new sterile water and normal cleaning and sterilization procedures were done. A second culture test has been done, and as of (b)(6) 2016, the results have not been reported by the test lab. This unit continues to be out of clinical service. According to the ccp, no patient infections have been linked to usage of this cooler heater unit or use of the other two cooler heater units at the hospital.

 
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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 Key5554175
MDR Text Key42567885
Report Number1828100-2016-00236
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,Followup
Report Date 05/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/07/2016
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 Received05/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2001
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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