A retrospective – what you do as you get older – look-back to a major event in the first 6 months of my new career: I take you back to 1979 and my introduction to patient safety and reporting.
October, 1979. The Biomedical Engineering department received a call that an external pacemaker was not functioning in the CCU procedure room. I arrived with a Medtronic pacemaker tester and found cardiologists attempting to stabilize a 57 year old male patient who had begun experiencing repeated and prolonged ectopic beats (otherwise healthy, in for pacemaker implant).
Clinicians tried 3 pacemakers and 3 pacing electrodes, with no capture spike on ekg strip. All external pacemakers tested OK. The patient continued to deteriorate – they were now defibrillating. I decided to take one of the sets of electrodes and pacemakers back to our lab for further examination.
While riding in the elevator I tried connecting the electrode to the lead wire connecting block, and found that the electrode did not appear to be fully inserted (a section of electrode contact area was exposed). In the lab, I confirmed this using an ohm meter, and quickly returned to the CCU treatment room only to find that the patient had expired (Had I noticed this during the resuscitation attempt, the outcome may have been different).
Later examination of the lead wire connection block on several new units showed a molding irregularity on the lead wire end of the block. All of the units inspected had a plastic molding of a lesser diameter on that side.
Out of the sterile wrap, if both screws were backed off the same number of turns, because plastic base diameter was smaller on one end, the tip of one screw would not back out as much as the other. In other words, because the end screw was effectively seated lower in the block, the same number of turns would result in the electrode passing under the first screw, but would butt up against the 2nd, thus not making positive contact with that connector.
We submitted this x-ray of the actual product plus a drawing along with our report.
The patient died – with the director of cardiology and many residents attending in the procedure room. Their assumption at the time was that the electrode pacing did not capture because it had been placed in massively infarcted tissue – “electromechanical dissociation.” Wrong.
I informed the cardiologists what had happened, but the hospital director initially refused to report the incident to the FDA. Shown here is the initial notice to the hospital director.
I filed a report to the FDA from my home.
USP asked for additional information.
Eventually the official hospital report was released.
After some back and forth, this was the conclusion.
Here is the end of this story:
Several months later, a new USCI salesman shows up. When asked about this product, he explains that, yes, the item is still shown in their catalog, but, “I can assure you that none leave our loading dock.” He then parroted the company line about there being no problem – we handed him a new package for him to demonstrate that there is no problem. I sometimes wonder how this affected him: he did it wrong; his patient would not have been paced.