ECMO FMEA #13 Failure to prevent ECMO circuit or system damage during intra hospital transport.

This ECMO FMEA was inspired by a recent PIRS II report (#111 of 2020 <https://anzcp.org/wp-content/uploads/reports/2020/PIRS-2020-ECMO.pdf>) of an ECMO circuit disruption during preparation for an intra hospital transport. A motorized bed collided with an ECMO system rupturing a temperature probe on the oxygenator. There was a large blood loss before the perfusionist could clamp the system off. While the perfusionist was obtaining the backup pump which was located in a different area the patient arrested. The patient was placed back on ECMO using the replacement circuit and eventually survived to be discharged home.

The report author suggests that ancillary personnel (in this case the orderly responsible for operating the motorized bed) be better trained. However, transport accidents such as this are always going to be freakish in nature. So, training may not anticipate actual incidents. The perfusionist or ECMO Specialist needs to maintain a heightened awareness of the risks of transport and coordinate everyone’s participation during the transport.

Also, he was the sole perfusionist with no perfusion educated assistance. This increases the risk for the patient should an incident occur.

I experienced a heightened awareness of the dangers of intrahospital ECMO transport when a wheel fell off the pump as I crossed an elevator threshold. The pump tipped precariously and the closing elevator doors threatened to damage the circuit and associated equipment. My accompanying assistant helped to stabilize the heavy pump and prevent damage from the closing doors. Afterwards I redesigned my system so that no vulnerable circuit parts or system equipment (except for the blood lines going to and from the patient) were outside of the protective confines of the pump stand platform. I also fixed the manufacturer’s defect on my ECMO pumps that caused the wheels to fall off on two different occasions.

Gary Grist RN CCP Emeritus

ECMO FMEA #13 Failure to prevent ECMO circuit or system damage during interhospital transport.

EFFECT:

1. Temporary termination of ECMO support if key equipment (sweep gas, power supply, pressure monitors, etc.) becomes inoperative.
2. Potential for excessive blood loss if circuit disrupted.
3. Shock and organ failure
4. Catastrophic termination of ECMO caused by accidental decannulation
5. Patient death by ECMO termination or accidental exsanguination.

CAUSE:

1. Human error from lack of coordination of all aspects of transport including instructions to ancillary personnel.

PRE-EMPTIVE MANAGEMENT:

1. Before intrahospital transport convene a time-out during which all personnel involved are instructed in the vulnerabilities of the ECMO system.
2. A portable jump kit containing any conceivable repair supplies for the ECMO system should be available during transport and attended by a second knowledgeable perfusionist or ECMO Specialist who can provide educated help should an ECMO system emergency occur.
3. A wet primed back-up pump should always be available in a nearby location.
4. A person should be appointed with the sole responsibility to secure and control the blood lines and cannulae to prevent accidental decannulation.
5. The surgeon should be notified of the transport and be available if accidental decannulation occurs.

MANAGEMENT:

1. If system damage occurs and can be quickly rectified in route, that should be done on site using supplies from the jump kit.
2. If the system damage cannot be rectified and the patient is at risk if ECMO is halted the transport should be terminated at the discretion of the perfusionist or ECMO Specialist and the patient removed to the area of the back-up pump.
3. If an accidental decannulation occurs, ECMO should be discontinued, the bleeding controlled and the patient resuscitated until re-cannulation can be accomplished.

RISK PRIORITY NUMBER (RPN):

1. Severity (Harmfulness) Rating Scale: how detrimental can the failure be:

1) Slight, 2) Low, 3) Moderate, 4) High, 5) Critical

(I would give this failure a High 4 RPN as long as back-up perfusion assistance is available during transport. If no accompanying back-up assistance, the RPN should be 5.)

1. Occurrence Rating Scale: how frequently does the failure occur:

1) Remote, 2) Low, 3) Moderate, 4) Frequent, 5) Very High

(The Occurrence is Low, so the RPN would be a 2.

1. Detection Rating Scale: how easily the potential failure can be detected before it occurs:

1) Very High, 2) High, 3) Moderate, 4) Low, 5) Uncertain

(The Detectability RPN equals 5. There is no way to predict what complication could occur during intrahospital transport.

1. Patient Frequency Scale:

1) Only a small number of patients would be susceptible to this failure, 2) Many patients but not all would be susceptible to this failure, 3) All patients would be susceptible to this failure.

(Only patients subject to intrahospital transport would be at risk. Many, but not all ECMO patients need transport, so the Frequency RPN would be 2.)

Multiply A*B*C*D = RPN.  The higher the RPN the more dangerous the failure mode.

The lowest risk would be 1*1*1*1* = 1 or 0.27%. The highest risk would be 5*5*5*3 = 375 or 100%. RPNs allow the perfusionist to prioritize the risk. Resources should be used to reduce the RPNs of higher risk failures first, if possible.

(The total RPN for this failure is 4*2*5*2 = 80; 80/375 = 21% possibility of an incident occurring in transport. If there is no educated back-up assistance during transport the risk would be higher; 5*2*5*2 = 100; 100/375 = 27%.)