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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MTA6900
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Coagulation Disorder (1779); High Blood Pressure/ Hypertension (1908); Alteration In Body Temperature (2682)
Event Date 12/04/2017
Event Type  Injury  
Manufacturer Narrative
The user facility confirmed that there were no long term adverse consequences to the patient involved. The user facility also identified that the device was evaluated by the biomed department of the hospital and the device was found to be operating properly. It was identified that the cause for this issue was due to the wrong temperature settings being selected. Feedback was provided to the user facility regarding checking the setting for the device and confirming appropriate settings are used before beginning therapy.
 
Event Description
It was reported that the customer used a mta-6900 with the device set at 42 degrees fahrenheit instead of 42 degrees celsius during surgery. It was alleged that the patients core body temp lowered during surgery and the patient became hypertensive and coagulopathic. This allegedly resulted in the patient requiring vasopressors & blood products.
 
Event Description
It was reported that the customer used a mta-6900 with the device set at 42 degrees fahrenheit instead of 42 degrees celsius during surgery. It was alleged that the patients core body temp lowered during surgery and the patient became hypertensive and coagulopathic. This allegedly resulted in the patient requiring vasopressors & blood products.
 
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Brand NameCAPITAL HYPER HYPOTHERMIA
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7133084
MDR Text Key100044258
Report Number0001831750-2017-00582
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMTA6900
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 Received12/04/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/31/2009
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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