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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT Back to Search Results
Model Number 809810
Device Problem False Alarm (1013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). As per the user facility's ccp, the unit would not cool and no leaking was noted. The field service representative (fsr) was unable to duplicate the reported complaint. The unit was tested for an extended period of time. The unit operated to the manufacturer's specifications. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, channel a on the heater cooler alarmed indicating more water was needed when the water was full. The cardioplegia (cpg) flow was turned off. 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 confirmed. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

 
Event Description

Per clinical review: toward the end of the procedure on (b)(6) 2017, the user facility had a heater/cooler that gave an error that the system needed water, even though the heater/cooler was full. The team did not need the cardioplegia circuit, therefore they chose to turn off the circulation. The error code will not allow cooling to occur, but since it was toward the end of the procedure, cooling of the patient or the cardioplegia was not needed. The unit was not changed out, the surgical procedure was not delayed. There was no associated blood loss, for the heater/cooler is an external device hooked up to the heat exchangers on the bypass circuit. The field service representative (fsr) attended to the unit and confirmed that the unit was working to specifications. The heater/cooler is used sparingly at the hospital, for they have replaced them with a different manufacturer's units.

 
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Brand NameTERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7007153
MDR Text Key92537436
Report Number1828100-2017-00506
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071521
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 12/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number809810
Device Catalogue Number809810
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 Received12/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2008
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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