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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 Device Alarm System (1012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/31/2018
Event Type  Malfunction  
Manufacturer Narrative

The fsr was unable to duplicate the reported complaint. There were no internal leaks or blockage causing the low water level alarm to be initiated. The direct current (dc) control board tested to specifications. The unit operated to the manufacturer's specifications.

 
Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was a continuous low water level alarm on channel b. 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. Per clinical review: during a cpb procedure on (b)(6) 2018, the heater cooler was giving the user a continuous low water level alarm on the cardioplegia side of the unit. This did not affect the performance of the machine, but was a nuisance to the staff in the room. The team opted to exchange the unit for another one, and had no issues for the remainder of the procedure. The field service representative (fsr) did a service check and found no functional issues. The clinical specialist corresponded with the perfusionist on how to resolve this issue when the water was diluted with the ice mixture. This incident did not delay the surgical procedure. There was no blood loss or harm associated with the issue.

 
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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 (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7635652
MDR Text Key112571447
Report Number1828100-2018-00330
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2018
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? No
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2008
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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