WRONG-ROUTE ERROR
Topical thrombin given systemically during surgery
A patient undergoing cardiac bypass surgery received Recothrom (thrombin topical [recombinant]) systemically instead of Thrombate III (antithrombin III [human]). Thrombate III is indicated in patients with hereditary antithrombin deficiency for treatment and prevention of thromboembolism and prevention of perioperative and peripartum thromboembolism. Thrombate III may be used via a cardiopulmonary bypass machine for patients who are identified as being heparin-resistant. The drug is administered to potentiate the heparin effect to meet predetermined activated clotting time (ACT) thresholds and allow for cardiopulmonary bypass. In contrast, Recothrom is a topical thrombin formulation applied to the surface of bleeding tissues to aid hemostasis in certain circumstances.
The error happened when the perfusionist typed "T-H-R-O-M" into the automated dispensing cabinet (ADC) intending to obtain the prescribed drug, Thrombate III. However, when the screen displayed Recothrom as an option, the perfusionist selected it in error.
The perfusionist removed Recothrom from the ADC, reconstituted it using a Luer syringe and a Luer transfer device provided inside the Recothrom carton, drew up the reconstituted drug, connected the syringe to an injection port on the bypass machine, and administered the drug. Monitoring the patient's ACT, the perfusionist saw that it was not prolonging and another dose of Recothrom, not antithrombin, was administered via the bypass machine. When the ACT was still not prolonging, the perfusionist called another perfusionist into the room.
The second perfusionist saw the box labeled "thrombin," immediately recognized the error, and notified the surgical team. The patient needed 11 vials of antithrombin III to reverse the effects of the systemically administered topical thrombin and was also anticoagulated with heparin. The patient responded well and experienced no adverse reactions from the error.
Topical thrombin must never be administered systemically. Accidental systemic use can lead to extensive intravascular clotting and death. This patient was fortunate that the surgical team was able to act quickly to reverse its effects.
Part of the problem is that "thrombin" appears in both drug names. One way to make a selection error less likely would be to list the names of these products in the electronic health record and the ADC only as "topical thrombin" and "antithrombin III" to promote proper drug identification.
Aside from the name similarity, both Recothrom and Thrombate III are available in cartons and require reconstitution. In the hospital where this error occurred, independent double-checks were not required, and perfusionists received no special training regarding medication handling. Either of these safety processes would have made this error less likely. The hospital is now adding medication administration training for new perfusion staff, standardizing workflows, and adding an independent double-check for certain medications, including these products, in the OR. Also, the topical thrombin product is being removed from the ADC in the OR and will be stored in a different location.
As shown in the photos, the carton of the Recothrom product used at this hospital contains Luer syringes and a Luer transfer device. Thrombin-JMI (thrombin topical [bovine]), which was also available at the hospital but is bovine-derived and not recombinant, does not have Luer devices in the carton. Instead, the carton includes a Mix 2 Vial, a needleless reconstitution system for vial-to-vial transfer. The Recothrom vial-and syringe packaging might mislead a practitioner into believing it is a parenteral product. Still, with either topical thrombin product, a Luer syringe with a needle could be used with the vials, thus allowing connection to a bypass machine injection port. An auxiliary label applied to prepared syringes to warn against I.V. injection may be helpful. Although the vials themselves are marked "Do Not Inject," that alone is not a reliable way to prevent this type of error.