MAUDE MDR 9805266

MDR report key
9805266
Report number
9805266
Event key
0
Event type
3
Date of event
2017-02-08
Date received
2020-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSPAC IVTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULARICU MEDICAL, INC.DRS* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-090

Event Narratives#

D

Patient 1

ECMO CIRCUIT MANIFOLD HAD WHITE AIR VENT CAP AT THE END THAT RN MISTAKENLY TURNED THE STOPCOCK OPEN TO ALLOW AIR TO INTO THE CIRCUIT AND INTO THE PATIENT (AIR EMBOLI). ECMO MANIFOLD HAD LASIX AND HEPARIN INFUSING INTO IT. LASIX WAS INFUSING VIA SYRINGE PUMP AND HEPARIN VIA ALARIS INFUSION PUMP. AIR ENTERED HEPARIN DRIP THAT WAS INFUSING INTO ECMO CIRCUIT. RN TURNED HEPARIN DRIP STOPCOCK TO THE OFF POSITION ON ECMO CIRCUIT MANIFOLD IN ORDER TO REMOVE THE AIR FROM ALARIS PUMP HEPARIN TUBING. WHEN DOING THIS AIR ENTERED THE ECMO CIRCUIT. IT WAS THEN NOTED THAT A WHITE AIR VENT CAP HAD BEEN PLACED PREVIOUSLY ONTO THE END OF THE MANIFOLD (USUALLY IT IS A RED DEAD END CAP). (AIR ENTERING THE DRIP TUBING WHILE ON ECMO WITH THE CAREFUSION ALARIS PUMPS IS AN ONGOING ISSUE WITH ALL OUR ECMO DRIPS). BUBBLE ALARM WARNING WENT OFF AND IMMEDIATELY THE ARTERIAL CANNULA WAS GRABBED TO STOP FORWARD FLOW; THEN OUR PROCESS OF CLAMPING THE ECMO CIRCUIT WAS INITIATED. UNFORTUNATELY AT THE TIME WE SAW AIR IN THE ARTERIAL CANNULA. THIS AIR WAS REMOVED BY USING THE DOUBLE CLAMP METHOD, WE ASSUMED THAT AIR HAD ENTERED THE ARTERIAL CANNULA.