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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. DUAL COOLER/HEATER; SARNS DUAL COOLER/HEATER
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TERUMO CARDIOVASCULAR SYSTEM CORP. DUAL COOLER/HEATER; SARNS DUAL COOLER/HEATER Back to Search Results
Model Number 11160
Device Problem Impedance Problem (2950)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the cooler heater unit set off the o/r alarms.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.
 
Manufacturer Narrative
The user facility's biomedical engineer (biomed) troubleshooted and found the leakage current to be 9 milliamps and found the thirty-four (34) degree thermostat was the problem.
 
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Brand Name
DUAL COOLER/HEATER
Type of Device
SARNS DUAL COOLER/HEATER
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson rd.
ann arbor, MI 48103
7346634145
MDR Report Key3982811
MDR Text Key20292975
Report Number1828100-2014-00536
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11160
Device Catalogue Number11160
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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