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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORP. HX2 TEMPERATURE MANAGEMENT SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS. Back to Search Results
Model Number 809810
Device Problem Failure to Pump (1502)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The field service representative (fsr) verified the unit would not pump and the low water level indicators on both channels were displayed. He removed the covers to troubleshoot and checked connectors. The fsr removed the water and replaced with tap water and the low water level indicators did not come on. After talking to the ccp, it was verified that he had put distilled water in the unit. The fsr performed preventive maintenance (pm) and release test of the device. The unit operated to manufacturer specifications and was returned to clinical use.
 
Event Description
It was reported that during a procedure (an isolated limb perfusion case), the heater cooler unit would not pump and would not pass the "self-test. " 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
(b)(4). The reported complaint was confirmed. Using distilled water in the unit will cause the low level alarms seen by the field service representative (fsr) and customer and disable the pumps. The fsr reviewed the instructions for use (ifu) requirements of not using distilled or sterile water in the unit with the customer. 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 NameHX2 TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-HX2 TEMPERATURE MANAGEMENT SYS.
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 Key5584188
MDR Text Key43586118
Report Number1828100-2016-00254
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071521
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 05/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received05/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2008
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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