FDA.reportPublic FDA data

MAUDE MDR 5019418

MDR report key
5019418
Report number
3003477173-2015-00002
Event key
0
Event type
3
Date received
2015-08-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DIANE HOWELL
Address
1905 COUNTY ROAD C ROSEVILLE 55113 US
Phone
651-651-6514
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CIRQLATORADVANCED CIRCULATORYBWFR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-200

Event Narratives#

D

Patient 1

ICU PATIENT, BEING TREATED FOR TBI, WAS BEING MECHANICALLY VENTILATED IN THE NEURO ICU. THE PATIENT SUFFERED A DESATURATION EVENT THE PREVIOUS DAY, WHICH WAS ATTRIBUTED TO A MUCUS PLUG. PATIENT WAS STABLE AND PLACED ON THE DEVICE AT 11:00 AM ((B)(6) 2015). THE AIRWAY PRESSURE WAS UNUSUALLY HIGH AND PROMPTED SEVERAL AIRWAY SUCTIONS. AIRWAY PRESSURE REMAINED MARGINALLY HIGH. DEVICE WAS OTHERWISE TOLERATED. SEVERAL HOURS INTO DEVICE USE, FIO2 WAS INCREASED (TO 60%) TO COMPENSATE FOR A DECREASE IN MONITORED ARTERIAL OXYGEN SATURATION (DECREASING TO 96%). DEVICE WAS TURNED OFF AFTER FOUR HOURS OF USE. 60 MINUTES AFTER THE DEVICE WAS TURNED OFF, THE PATIENT SUFFERED A DESATURATION, WITH SATS REACHING 70%. PATIENT WAS MANUALLY VENTILATED WITH 100% OXYGEN AND EMERGENCY BRONCHOSCOPY WAS PERFORMED. A MODERATE AMOUNT OF MUCUS WAS REMOVED FROM THE PATIENT'S LEFT LUNG. AFTER SUCTIONING, THE OXYGEN SATURATION RETURNED TO NORMAL. THE PATIENT WAS RETURNED TO MECHANICAL VENTILATION.