Description of Event or Problem · 0
SITUATION: A CRITICAL ARRHYTHMIA DETECTION THRESHOLD WAS NOT UPDATED DURING ROUTINE SOFTWARE MAINTENANCE WITH THE OUTSIDE VENDOR PREVENTICE. BACKGROUND: PREVENTICE IS AN OUTSIDE VENDOR SELECTED YEARS AGO BY THE HVC (HEART AND VASCULAR CENTER) SYSTEM FOR MOBILE CARDIAC TELEMETRY AND CONTINUOUS ECG MONITORING. IN JANUARY 2024, PREVENTICE PERFORMED A ROUTINE SOFTWARE UPDATE, HOWEVER THE DETECTION THRESHOLD SETTING FOR VT (VENTRICULAR TACHYCARDIA ) WAS NOT UPDATED. AS A RESULT, PATIENTS WHO WORE MOBILE CARDIAC TELEMETRY DEVICES AND EXPERIENCED EPISODES OF VT BETWEEN [REDACTED DATE] ¿ [REDACTED DATE] WERE NOT INCLUDED IN THE COMPANY¿S REPORTS. ASSESSMENT: BETWEEN [REDACTED DATE] AND [REDACTED DATE], THE [REDACTED NAME] ENROLLED APPROXIMATELY 1300 PATIENTS FOR MOBILE CARDIAC TELEMETRY AND/OR CONTINUOUS ECG MONITORING. LATE FRIDAY AFTERNOON ([REDACTED DATE]), THE [REDACTED NAME] HVC SYSTEM WAS NOTIFIED OF 65 CRITICAL VT INCIDENTS ACROSS THE SYSTEM. THE ISSUE WAS DISCOVERED BY BOSTON SCIENTIFIC CARDIAC DIAGNOSTICS DURING NORMAL, ONGOING AUDITS, AND THE REPORT CONFIGURATION SETTING WAS UPDATED ON [REDACTED DATE], RESOLVING THE ISSUE. RECOMMENDATION: PREVENTICE HAS NOTIFIED ALL PROVIDERS INVOLVED AND WILL SEND THE NEWLY FOUND CRITICAL ALERTS TO THE SITES ON [REDACTED DATE]. FINAL AMENDED REPORTS WILL BE UPDATED IN EPIC A WEEK LATER. WE ARE COLLABORATING WITH BOTH INTERNAL/EXTERNAL STAKEHOLDERS AND SHARING THIS FOR SITUATIONAL AWARENESS AND SYSTEM DISTRIBUTION. MANUFACTURER RESPONSE FOR CARDIAC MONITORING PROGRAM, PREVENTICE CARDIAC MONITORING PROGRAM (PER SITE REPORTER).