Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Cardiopulmonary Perfusion; OR / Surgery

Device Factors
Device failure; Random component failure

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Failure to deliver therapy; Hemolysis; Ischemia

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Pumps, Extracorporeal Perfusion [13-203]

Failure of a Centrifugal Heart-Lung Bypass Pump



Hazard [Health Devices Jul 1986;15(7):213]

Problem

A member hospital reported that while a patient was on heart-lung bypass, the rate control of the centrifugal arterial blood pump used to perfuse the patient malfunctioned. Before the malfunction, the pump had been set to deliver 3.5 L/min. As a result of the malfunction, the pump would deliver only its maximum flow rate, 9.9 L/min. Fortunately, a spare roller pump was available on the heart-lung console, and the procedure was completed without any apparent harm to the patient.

Discussion

After discussing the reported incident with the manufacturer and the hospital, we believe that the malfunction was most likely due to an isolated component failure, which appears unlikely to recur. The incident does, however, raise a general concern about these pumps. Because pump failures occasionally occur during heart-lung bypass procedures, it is advisable for perfusionists to maintain a backup arterial roller pump on the heart-lung consoles. Although the centrifugal pump and most roller pumps have hand cranks that permit manual pumping, they are difficult to use, and they divert the attention of the perfusionist away from the critical responsibility of monitoring the patient.

Recommendations

  1. Alert perfusionists to this report.
  2. Provide and maintain a spare arterial roller pump on all heart-lung consoles. (Using a roller pump as a spare is preferable to using a centrifugal pump because roller pumps can provide both positive and negative pumping pressures. Thus, they can be used to replace an arterial pump or a suction pump if either one malfunctions.)
  3. Ensure that perfusionists develop and practice a procedure to follow in the event of pump failure so that they can transfer the pumps quickly, disturbing the bypass circuit as little as possible. Test all spare pumps, and set them to the anticipated flow rates of the arterial pump during preperfusion procedures to minimize delay in changing pumps. Perfusionists using a centrifugal arterial pump during bypass should make the arterial line between the oxygenator and arterial pump long enough during preperfusion setup to permit installation of the backup roller pump. Thus, if the centrifugal pump fails during the bypass procedure, they can quickly install the roller pump in series with the centrifugal pump. (The centrifugal pump head is nonocclusive and will present only a minor pressure drop if left in the arterial line.)

UMDNS Term

Pumps, Extracorporeal Perfusion [13-203]

Cause of Device-Related Incident

Device factors: Device failure; Random component failure

Mechanism of Injury or Death

Failure to deliver therapy; Hemolysis; Ischemia


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