Catalog Number MTA6900 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Coagulation Disorder (1779); High Blood Pressure/ Hypertension (1908); Alteration In Body Temperature (2682)
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Event Date 12/04/2017 |
Event Type
Injury
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Event Description
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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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Manufacturer Narrative
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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.
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Event Description
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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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Search Alerts/Recalls
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