BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ED PULSECHECK

    MDR report key: 2265467 · Received August 22, 2011

    Report

    Report Number
    3005244943-2011-00003
    Event Type
    Malfunction
    Date Received
    August 22, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    PICIS, INC.
    Product Code
    NSX
    Removal / Correction Number
    3005244943-8/9/11-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REC'D AND INVESTIGATED TWO SIMILAR CUSTOMER REPORTS OF MALFUNCTION INVOLVING PICIS EMR SOFTWARE APPLICATION. CUSTOMER CLINICIANS REPORTED OBSERVING ERRONEOUS RESULTS WITH THE DEVICE ALLERGY INTERACTIONS FEATURE USED IN CHECKING MEDICATION ORDERS AGAINST DOCUMENTED PT ALLERGY HISTORY. THERE WERE NO ASSOCIATED REPORTS OF MEDICATION ERROR OR PT INJURIES AS A RESULT. OUR INTERNAL INVESTIGATION HAS CONFIRMED AN ERROR CONDITION EXISTS WITHIN SOFTWARE CODE FOR THE DEVICE, WHEN USED IN CONJUNCTION WITH MULTUM 3RD PARTY DRUG DATABASE CONTENT. THE WORKFLOW IMPACTED IS AS FOLLOWS: PT HAS A DOCUMENTED ALLERGY IN OUR DEVICE APPLICATION TO A SPECIFIC DRUG OR CATEGORY OF DRUGS, CLINICIAN ATTEMPTS TO PLACE AN ORDER FOR A MULTI-COMPONENT MEDICATION WITH ONE OF THE COMPONENTS BEING IN THE SAME CATEGORY AS THE PT'S ALLERGY, APPLICATION DOES NOT DISPLAY THE APPROPRIATE ALLERGY INTERACTION NOTIFICATION. FOR EXAMPLE: PT HAS AN ALLERGY TO CATEGORY OF 'PENICILLINS' AND THE USER ATTEMPTS TO ORDER 'ZOSYN' (PIPERACILLIN/TAZOBACTAM) - NO ALLERGY INTERACTION NOTIFICATION (PIPERACILLIN BELONGS TO THE ALLERGY CATEGORY OF 'PENICILLINS') IS DISPLAYED. IT SHOULD BE NOTED THAT IF THE COMPONENT IS THE SAME DRUG AS THE PT ALLERGY, THE ALLERGY CHECKING WILL DISPLAY CORRECTLY. ROOT CAUSE: OUR INVESTIGATION HAS CONCLUDED THAT THE ROOT CAUSE RELATES TO A SOFTWARE CODING ERROR INTRODUCED DURING DEVELOPMENT OF SOFTWARE RELEASE V5.0 SERVICE PACK L, WHICH WAS NOT DETECTED DURING VERIFICATION AND VALIDATION TESTING. SERVICE PACK L WAS RELEASED ON (B)(4) 2011 AND WAS SUBSEQUENTLY CARRIED FORWARD INTO SERVICE PACK M RELEASE, ON (B)(4) 2011. WE HAVE CONFIRMED THAT NO EARLIER OR LATER VERSIONS OF SOFTWARE ARE AFFECTED. CORRECTIVE ACTION(S): THE FOLLOWING CORRECTIVE MEASURES HAVE BEEN DEPLOYED TO PREVENT FURTHER OPPORTUNITY FOR THIS ERROR TO BE EXPERIENCED IN THE FIELD: AFFECTED SERVICE PACK HAS BEEN REMOVED FROM AVAILABILITY ON OUR USER COMMUNITY WEBSITE. IN ACCORDANCE WITH FDA QSR 21 CFR SUBCHAPTER H PART 806, WE HAVE ISSUED A WRITTEN COMMUNICATION TO ALL POTENTIALLY AFFECTED CLIENTS, EXPLAINING THE POTENTIAL FOR THIS ERROR, ALONG WITH INSTRUCTIONS TO MONITOR DOCUMENTED PT ALLERGIES CLOSELY WHEN PRESCRIBING MEDICATION ORDERS IN OUR DEVICE APPLICATION, USING MULTUM DRUG DATABASE CONTENT. ON (B)(4), A SOFTWARE SOLUTION WAS RELEASED IN SERVICE PACK N FOR V5.0, WHICH WE ARE CURRENTLY COORDINATING IMPLEMENTATION WITH ALL POTENTIALLY AFFECTED CLIENTS. WE WILL TRACK THE PROGRESS ON THIS FIELD CORRECTION AND COORDINATE THIS INFO WITH OUR LOCAL FDA DISTRICT RECALL COORDINATOR. AN INTERNAL CAPA INVESTIGATION IS IN PROGRESS TO REVIEW INTERNAL PROCESSES FOR OPPORTUNITIES WHERE IMPROVEMENT IS NEEDED TO PREVENT THIS TYPE OF ERROR IN THE FUTURE. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING A PT ON THE TRACKING BOARD THAT HAS A PENICILLIN ALLERGY, BUT WHEN ZOSYN ORDER WAS DOCUMENTED IN THE ED PULSECHECK (ELECTRONIC MEDICAL RECORD) SOFTWARE APPLICATION, IT DID NOT DISPLAY APPROPRIATE ALLERGY CHECKING NOTIFICATION, YET IT DID FOR MAXIPIME. THERE WERE NO REPORTS OF PT IMPACT OR INJURY AS A RESULT OF THIS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ED PULSECHECK S/W TRANSMISSION & STORAGE PT DATA NSX PICIS, INC. 2125

    Patients

    Seq Age Sex Outcome Treatment
    1