| 1,000 Case Set | 57,452 Case Set | ||||||||
| Adverse Event Type with Description | Events Identified by Manual Review | Events Identified by the System | Events Identified by the System and Verified by Manual Review | Events Identified by the System | Events Identified by the System and Verified by Manual Review | Positive Predictive Value of the System | Events Identified by Traditional Event Detection | Events Identified by Both the System and by Traditional Event Detection | Proportion of Traditionally Detected Events Detected by the System |
| 803. Hemorrhage or hematoma requiring drainage, evacuation, or other procedural intervention* † | 1 | 4 | 1 | 230 | 107 | 0.47 | 52 | 28 | 0.54 |
| 402. New documented deep venous thrombosis (excludes superficial thrombophlebitis) | 9 | 6 | 5 | 204 | 105 | 0.51 | 28 | 10 | 0.37 |
| 819. Unplanned operation or return to reoperation (excludes nonanesthesia procedures, procedures commonly sequential or repeated)* † | 8 | 2 | 0 | 172 | 80 | 0.47 | 54 | 18 | 0.33 |
| 808. Postoperative wound infection requiring drainage (excludes contaminated or dirty case)* † ‡ | 9 | 2 | 1 | 137 | 47 | 0.34 | 70 | 8 | 0.11 |
| 801. Procedure-related injury requiring repair, removal of an organ, or other procedural intervention (excludes intended injuries based on disease process, anatomical structure, lack of alternative approach)* † | 2 | 1 | 0 | 128 | 39 | 0.30 | 22 | 14 | 0.64 |
| 302. Intravascular catheter–related volume overload leading to pulmonary edema (excludes secondary to acute myocardial infarction or patients with predisposing conditions; congestive heart failure, cardiac disease, renal failure/insufficiency, hemodynamic instability, or critically ill) | 3 | 1 | 0 | 96 | 54 | 0.56 | 0 | 0 | — |
| 401. New, acute pulmonary embolism, confirmed or suspected and treated (excludes suspected cause of sudden death with no autopsy to confirm)‡ | 2 | 1 | 1 | 95 | 61 | 0.64 | 12 | 5 | 0.42 |
| 938. Malfunction of equipment during treatment or diagnosis or a defective product with death or serious injury§ | 1 | 3 | 1 | 94 | 44 | 0.47 | 2 | 1 | 0.50 |
| 806. Displacement, migration, or breakage of an implant, device, graft, or drain* † | 3 | 4 | 2 | 70 | 24 | 0.34 | 14 | 1 | 0.07 |
| 604. Perioperative/periprocedural acute myocardial infarction (excludes multiple trauma, abdominal aortic aneurysm rupture)* ‡ ‖ | 3 | 3 | 1 | 66 | 26 | 0.39 | 9 | 3 | 0.33 |
| 605. Perioperative/periprocedural death (excludes multiple trauma, abdominal aortic aneurysm rupture)* ‡ ‖ | 0 | 0 | 0 | 58 | 12 | 0.21 | 4 | 1 | 0.25 |
| 805. Wound dehiscence requiring repair* ‡ | 1 | 4 | 1 | 43 | 22 | 0.51 | 8 | 5 | 0.63 |
| 301. Intravascular catheter-related necrosis or infection requiring repair, regardless of location of repair (excludes exclusive treatment with packs, intravenous catheter change, medications, wound irrigation) | 0 | 0 | 0 | 29 | 10 | 0.34 | 5 | 4 | 0.80 |
| 603. Perioperative/periprocedural cardiac arrest with successful resuscitation (excludes intentional arrest during cardiopulmonary procedures, multiple trauma, abdominal aortic aneurysm rupture)* ‡ ‖ | 0 | 2 | 0 | 28 | 6 | 0.21 | 0 | 0 | — |
| 751. Falls resulting in x-ray–proven fractures, subdural or epidural hematoma, cerebral contusion, traumatic subarachnoid hemorrhage and/or internal trauma (excludes soft tissue injuries) | 1 | 0 | 0 | 26 | 15 | 0.58 | 22 | 5 | 0.23 |
| 601. Perioperative/periprocedural new central nervous system deficit (excludes direct central nervous system procedure)* ‡ ‖ | 5 | 1 | 1 | 21 | 5 | 0.24 | 2 | 0 | 0.00 |
| 807. Thrombosed distal bypass graft requiring repair (excludes arteriovenous grafts and fistulas used for dialysis)* ‡ | 2 | 1 | 1 | 15 | 7 | 0.47 | 3 | 1 | 0.33 |
| 602. Perioperative/periprocedural new peripheral nervous system deficit with motor weakness (excludes direct procedures on specific nerve or sensory symptoms without weakness)* ‡ ‖ | 0 | 1 | 0 | 10 | 8 | 0.80 | 2 | 0 | 0.00 |
| 804. Anastomatic leakage requiring repair* † | 1 | 0 | 0 | 10 | 8 | 0.80 | 4 | 3 | 0.75 |
| 501. Laparoscopic unplanned conversion to open procedure because of injury and/or bleeding (excludes diagnostic laparoscopy with planned conversion or conversion based on findings, conversions based on difficulty identifying anatomy) | 0 | 0 | 0 | 10 | 4 | 0.40 | 1 | 1 | 1.00 |
| 303. Intravascular catheter–correlated pneumothorax, regardless of size or treatment (excludes nonintravascular related such as those resulting from lung biopsy, thoracentesis, permanent pacemaker insertion, and others) | 0 | 0 | 0 | 8 | 6 | 0.75 | 3 | 1 | 0.33 |
| 913. Unintentionally retained foreign body due to inaccurate surgical count or technique break | 0 | 0 | 0 | 8 | 2 | 0.25 | 0 | 0 | — |
| 853. Ruptured uterus† | 1 | 1 | 1 | 6 | 4 | 0.67 | 0 | 0 | — |
| 201. Aspiration pneumonia/pneumonitis in a nonintubated patient related to conscious sedation (excludes patients intubated/on a ventilator or with a known history of chronic aspiration) | 0 | 0 | 0 | 5 | 1 | 0.20 | 0 | 0 | — |
| 701. Second- or third-degree burn in the hospital (excludes first-degree burn) | 1 | 0 | 0 | 4 | 2 | 0.50 | 0 | 0 | — |
| 851. Hysterectomy in a pregnant woman† | 0 | 0 | 0 | 3 | 2 | 0.67 | 1 | 1 | 1.00 |
| 917. Unexpected loss of limb or organ# | 0 | 0 | 0 | 3 | 1 | 0.33 | 0 | 0 | — |
| 108. A medication error that resulted in permanent patient harm¶ | 0 | 0 | 0 | 3 | 0 | 0.00 | 0 | 0 | — |
| 109. A medication error that resulted in a near-death event (anaphylaxis, cardiac arrest)¶ | 0 | 0 | 0 | 3 | 0 | 0.00 | 0 | 0 | — |
| 921. Crime resulting in death or serious injury§ | 0 | 0 | 0 | 2 | 1 | 0.50 | 1 | 0 | 0.00 |
| 852. Inverted uterus† | 0 | 0 | 0 | 1 | 1 | 1.00 | 0 | 0 | — |
| 911. Wrong patient, wrong site (surgical procedure) | 0 | 0 | 0 | 1 | 0 | 0.00 | 0 | 0 | — |
| 915. Unexpected death§ | 2 | 0 | 0 | 1 | 0 | 0.00 | 0 | 0 | — |
| 110. A medication error that resulted in a patient death¶ | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 854. Circumcision requiring repair | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 912. Incorrect procedure of treatment (invasive) | 2 | 0 | 0 | 0 | 0 | — | 1 | 0 | 0.00 |
| 916. Cardiac and/or respiratory arrest requiring BLS/ACLS intervention# | 2 | 0 | 0 | 0 | 0 | — | 1 | 0 | 0.00 |
| 918. Impairment of limb (limb unable to function at same level before occurrence)# ** | 2 | 0 | 0 | 0 | 0 | — | 1 | 0 | 0.00 |
| 919. Loss or impairment of bodily functions (sensory, motor, communication or physiologic function diminished from level before occurrence)# ** | 4 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 920. Errors of omission (related to patient's underlying condition) with death or serious injury§ | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 922. Suicide and attempted suicides with death or serious injury§ | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 923. Elopement from hospital death or serious injury§ | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 961. Infant abduction | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 962. Infant discharged to wrong family | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| 963. Rape by another patient or staff | 0 | 0 | 0 | 0 | 0 | — | 0 | 0 | — |
| Total | 65 | 32 | 16 | 1,590 | 704 | 322 | 110 | ||
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↵* Exclude cardiac related.
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↵† Exclude birth related.
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↵‡ Include readmissions.
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↵§ Serious injury includes arrest, impairment of limb, loss of limb, or impairment of bodily functions.
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↵‖ Within 48 hours.
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↵¶ Exclude adverse drug reaction that was not the result of a medication error.
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↵# Exclude unexpected adverse occurrence directly related to the natural course of patient's condition (i.e., terminal or severe illness present on admission).
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↵** Present at discharge or for at least two weeks if patient not discharged.
