This incident was not reported to csz by the user and no further information can be found.Csz has made good faith efforts by contacting the fda for more information regarding the incident.The fda responded and is not able to release any more information concerning the name of the user facility, patient information, or the serial number of the device.User stated that previous temperature management systems did not have this issue.It is believed that the user facility understood that the device was programmable (set hourly increments to desired set temp).The biii does not have a programmable feature.Csz examined previous complaint data and product documentation and concluded the user facility most likely did not set the device correctly (temperature/mode); therefore user error was a factor in the incident.No further patient outcome was provided.
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Through csz's post market surveillance, a report was found on fda's maude database concerning the blanketroll iii's (biii) ineffectiveness to maintain temperature.The user facility alleged that the biii achieves the therapeutic temperature but then is ineffective at maintaining the temperature.The user states the biii takes hours to rebound but then states the fast rewarm caused the patient to become hypotensive, tachycardic, unstable, and experienced electrolyte abnormalities beyond the anticipated levels due to constant temperature shifts.The patient was treated iv fluids and medications.
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