BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMPAX CV REPORTING

    MDR report key: 2549037 · Received April 19, 2012

    Report

    Report Number
    1225058-2012-00008
    Event Type
    Other
    Date Received
    April 19, 2012
    Date of Event
    January 4, 2012
    Report Date
    April 19, 2012
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AFTER THE EXPORT OF THE PT STUDY REPORT TO THE HIS, THE HOSPITAL REPORTED A PT RECEIVED THE WRONG TREATMENT BASED ON THE MIS-ATTRIBUTION OF THE HIS REPORT. BASED ON THE LOW EJECTION FRACTION (EF) THAT WAS SHOWN WITHIN THE REPORT CONTAINED IN HIS, A NURSE ASKED A DOCTOR TO DECREASE THE INTRAVENOUS FLUIDS (IV). NO PT HARM WAS REPORTED. THE NURSE MANAGER REPORTED THAT A MORE APPROPRIATE TREATMENT WOULD HAVE BEEN ADMINISTERED HAD THE CORRECT PT REPORT BEEN IN PLACE, BUT THAT THERE HAD BEEN NO REPORT OF ADVERSE OUTCOME AS A RESULT OF DECREASING THE VOLUME OF IV FLUID DELIVERED TO THE PT. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNK, AS INVESTIGATION CONTINUES TO ADDRESS THE ISSUE. SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ROOT CAUSE AND CORRECTIVE ACTION IS DETERMINED.

    Description of Event or Problem · 1

    PT STUDY REPORT IS INTERMITTENTLY EXPORTED TO THE WRONG PT WITHIN HIS. REPORT WAS CREATED IN IMPAX CV REPORTING AND CONVERTED INTO ADOBE ACROBAT PDF VERSIONS, (VIA A 3RD PARTY TOOL CALLED (B)(6)) FOR PRESENTATION IN IMPAX CV REPORTING AND THE HOSPITAL'S INFO SYSTEM (HIS). THE HOSPITAL REPORTED IN THIS EVENT, A PT RECEIVED THE WRONG TREATMENT BASED ON THE MIS-ATTRIBUTION OF THE HIS REPORT. BASED ON THE LOW EJECTION FRACTION (EF) THAT WAS SHOWN WITHIN THE REPORT CONTAINED IN HIS, A NURSE ASKED A DOCTOR TO DECREASE THE INTRAVENOUS FLUIDS (IV). NO PT HARM WAS REPORTED. THE NURSE MANAGER REPORTED THAT A MORE APPROPRIATE TREATMENT WOULD HAVE BEEN ADMINISTERED HAD THE CORRECT PT REPORT BEEN IN PLACE, PUT THAT THERE HAD BEEN NO REPORT OF ADVERSE OUTCOME AS A RESULT OF DECREASING THE VOLUME OF IV FLUID DELIVERED TO THE PT. THE ROOT CAUSE OF THIS EVENT IS CURRENTLY UNK, AS INVESTIGATION CONTINUES TO ADDRESS THE ISSUE. SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ROOT CAUSE AND CORRECTIVE ACTION IS DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV REPORTING SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ AGFA HEALTHCARE CORP. CV SUITE 7.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1