November 8-the case of KF

On November 8, 1994, KF, a five-month-old boy, underwent surgery to repair a complete atrioventricular canal defect. In addition, he underwent closure of an atrial septal defect, ligation of a patent ductus arteriosus and repair of his mitral valve.

Witnesses gave differing accounts and differing interpretations of events that took place shortly before the team went on bypass. The controversy revolved around the administration of heparin. In order to conduct bypass, the patient's blood must be treated with heparin to prevent it from clotting. If blood is passed through the heart-lung machine without heparinization, it will begin to clot immediately, with potentially fatal results.

The heparin was measured in advance and kept in a sterile area in the operating room. Generally, a scrub nurse handed the heparin to Odim or his assistant, who would then inject it into a small part of the right atrium, known as the right atrial appendage. From there, the heparin would enter and mix with the blood in the rest of the heart.

About five minutes after the heparin was given, the perfusionists normally measured what was referred to as the activated clotting time (ACT), to ensure that the patient was fully heparinized. A blood sample was injected into what is called an ACT machine. The machine had a timer that measured how long the blood took to clot. Preparation for cannulation generally took place while the ACT was being measured.

According to Wong, in the KF case he noted that Odim was inserting the aortic cannula without having asked for the ACT. Concerned about this, Wong asked Odim if he had already injected in the heparin into the heart. According to Wong's testimony, Odim said that he had not done so and then proceeded to inject the heparin. After waiting until the ACT was measured, Odim finished inserting the cannula. Wong said that it was normal to administer the heparin before inserting the aortic cannula. He also said that while this incident was not as disturbing to him as were the KZ and JB cases, he was left feeling more uncomfortable.

In the notes that she was keeping on problematic incidents during this period, Youngson made the following entry regarding this operation:

Cannulae in and circuit divided and hooked up all before the HEPARIN given. Usually given by assistant through the R.A. APPENDAGE. Surgeon did not ask for the Activated Clotting Time before he cannulated, de-aired and hooked up the aortic cannula. (Exhibit 20, Document 278 D)

Youngson testified that, during cannulation, she noted that the ACT timer was not ticking. However, she said nothing right away. She was asked who drew it to Odim's attention that the heparin had not been administered.

I think the perfusionists picked it up. To be honest, I can't remember. I was standing there watching it and thinking, should I say something? I was thinking, well, I will just wait a little longer.

First of all, I couldn't believe that we hadn't done this because it's so routine, it's just one of the things that you sort of do as you go along. I thought maybe I missed it, maybe somehow, maybe I was writing in the chart or something and I just didn't see this. So I didn't want to say anything at that point in time until I was sure that this was actually what was going on. So I just sort of hung back for a minute or two and sort of watched.

But nothing was happening with this machine, it wasn't ticking off the seconds. So, finally, I don't remember who it was that said, hey, we haven't given the heparin. And everybody said whoa, stop. (Evidence, page 8,620)

While Odim did not connect the event with the KF case, he did recall this incident. He gave the following account.

I do remember an incident in which we had cannulated and the heparin was sort of lying on the nursing tray, and I had indicated to the perfusionist to go on pump, and the nurse mentioned that, oh, we had not given the heparin yet. And so we gave the heparin and then we went on pump.

Q: Had you gone on pump without giving the heparin, what are the potential consequences?

A: Hopefully, we wouldn't have done that, because the perfusionist's job, before he turns on the pump, is to be sure there is an ACT, and an ACT had not been measured. One of the checks and balances in the system is the perfusionist's responsibility is to be sure that the ACT is greater than 400 seconds before going on pump.

At any rate, if you were to go on pump without heparinizing, you run the risk of clotting the system, pump and cannulas. (Evidence, page 25,805)

Odim said that the standard procedure was for him to give the heparin in the right atrial appendage, except in repeat operations, when the anaesthetist would administer the heparin. He said that, in this case, one of the perfusionists apologized to him. For his part, Odim said, he thanked the nurse for bringing it to his attention and the operation went forward.

While it appeared that the incident with the heparin had no long-term impact on KF's health, it served to further erode relations among team members and confidence within the team.