An extensive report from the manufacturer identified fibrin build up within the first oxygenator and no fault with the device. The second oxygenator and circuit were not kept for investigation. As part of a tender process, the oxygenators in use for this case were new to the department.
A Comprehensive Investigation Report from the institution revealed that it has not been possible to conclusively identify contributory factors that led to the patient’s death. There was no inquest. Two possible explanations in that report were:
- Possible unidentified patient coagulopathy (? Antiphospholipid syndrome).
- New oxygenator device in use during surgery.
It is important to note that neither explanation can be fully established or eliminated.
All standard protocol was followed during the procedure and all ACT results were well above the necessary threshold throughout the case. Inadvertent protamine administration was ruled out.
This incident has led a focus on awareness in the following areas:
- A hypercoagulable disorder may play a role in oxygenator failure. Any indication of such a state may call for improved point of care testing. Anti-Phospholipid Syndrome which occurs in 2% of the population. Antibodies present in patients with Antiphospholipid syndrome (APLS) are reported to affect a kaolin ACT. These antibodies attack some fats and proteins in the blood causing it to clot. Blood becomes stickier increasing the risk of blood clots. In a patient with known APLS, a celite ACT is recommended with a higher target value and plotting of heparin/ACT titration curves pre-operatively to determine patient-specific target ACT values. Heparin concentrations >3u/ml should be considered. Use of the HepCon system would prove valuable. Antifibrinolytic agents are not recommended.
- When evaluating any new equipment, the whole surgical team should be made aware at the team briefing.
- Any incidents, where faulty devices have been proved, should be reported to the MHRA as a precaution.
- Any device or disposable with suspected fault should be retained for investigation along with all serial
and lot numbers.
- Consideration should be given to recirculation of the blood remaining in the pump during any significant period where CPB has been terminated but where the cannula may remain in situ. This will prevent the blood from stagnating. Consider taking a sample for ACT analysis and regularly flushing the cannulae.
- During low flow CPB (used here for the assistance of IABP therapy), ensure that the minimum flow rate for the oxygenator in use is achieved or exceeded. This minimum flow rate will be quoted in the manufacturers Instructions for Use and should be incorporated into the departmental protocols.