BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE ASSEMBLY,GENERATOR KIT W_RT132 CIRCUITS

    MDR report key: 5749318 · Received June 24, 2016

    Report

    Report Number
    8030673-2016-00177
    Event Type
    Death
    Date Received
    June 24, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 25, 2016
    Manufacturer
    BD
    Product Code
    BZD
    PMA / PMN Number
    K031745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE AVAILABLE FOR EVALUATION, DEVICE EVALUATED BY MFR?, EVALUATION CODES, ADDITIONAL MFR NARRATIVE. RESULTS OF INVESTIGATION: THE REPORTED LOT NUMBER DOES NOT BELONG TO A CAREFUSION/BD PRODUCT THUS IT IS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORDED FOR THE REPORTED LOT NUMBER. DURING THE COMPLAINT TREND REVIEW NO TREND WAS FOUND. THREE SAMPLES WERE RECEIVED FOR EVALUATION. ONE UNIT WAS FOUND TO BE USED; THIS UNIT WAS RECEIVED WITH MISSING COMPONENTS THE OTHER TWO SAMPLES WERE INTAKE. IT IS NOT POSSIBLE FOR CAREFUSION/BD TO CONDUCT A FUNCTIONAL INSPECTION ON THE PROVIDED SAMPLES, BECAUSE THIS PART IS PROVIDED BY AN EXTERNAL VENDOR THEREFORE THE SAMPLES HAVE BEEN SENT TO THE SUPPLIER FOR FURTHER EVALUATION. A SUPPLIER CORRECTIVE ACTION REQUESTED HAS BEEN ISSUED TO REQUEST THE ROOT CAUSE OF THE ISSUE REPORTED AND THE APPLICABLE ACTION PLAN. CAREFUSION/BD HAS NOT RECEIVED ANY OF THE REQUESTED INFORMATION FROM THE SUPPLIER AT THIS TIME. THIS ACTION REQUEST WILL REMAIN OPEN.

    Additional Manufacturer Narrative · 1

    CUSTOMER ADVOCACY HAS REACHED OUT TO CUSTOMER TO PROVIDE SAMPLE FOR THE INVESTIGATION. SHIPPING DOCUMENTS HAVE BEEN PROVIDED TO THE CUSTOMER. AT THIS TIME WE ARE CURRENTLY WAITING FOR THE SAMPLE. ONCE THE INVESTIGATION IS COMPLETE OR IF WE RECEIVE ANY ADDITIONAL INFORMATION WE WILL PROVIDE A SUPPLEMENTAL REPORT.(B)(4). AT THIS TIME, CAREFUSION HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.

    Description of Event or Problem · 1

    ON 3RD OF MAY AT 9:25AM WE RECEIVED A CALL FROM NURSE (B)(6) OF (B)(6) HOSPITAL PEDIATRIC INTENSIVE CARE UNIT THAT THEY HOOKED A PATIENT ON SIPAP, BUT COULD NOT DISCERN/APPRECIATE THE GRAPHICAL WAVE FORM WITH A SET HIGH PRESSURE. THE PATIENT WAS CONSCIOUS ON THE SIPAP LP DEVICE WITH A NASAL PRONGS INTERFACE. THE PATIENT¿S FATHER WAS BEDSIDE HE DECIDED TO INSPECT FOR THE PROBABLE ROOT CAUSE. HE STARTED ON THE HUMIDIFIER DOME CONNECTION, HEATED WIRE, TEMP PROBE AND THE GENERATOR AND NOTICED ALL WERE WELL CONNECTED, AND ALL IN PLACE. THE MACHINE WAS SWITCHED OUT, BUT A SIMILAR FAILURE WAS NOTED. ONE CIRCUIT WAS USED WITH BOTH SIPAP MACHINES. DUE TO THIS INSTANCE THERE WAS AN OPEN DISCUSSION WITH THE NURSE AND THE DOCTOR IN CHARGE OF THE PATIENT. THE SALES REP STATED THAT THE ¿RESPIRATORY THERAPIST WHOM THEY CALL DR. (B)(6) STATED THAT HE HAD ALREADY DONE SOME INVESTIGATION ON ALL OF THE CONNECTIONS FOR A POSSIBLE REASON WHY THE PRESSURE HIGH IS NOT SHOWING. HE CONCLUDED THAT IF THERE IS NO ISSUE ON THE SIPAP MACHINE THEN IT IS PROBABLY CIRCUIT ITSELF. THIS COULD BE WHY THERE IS AN ABSENCE OF HIGH PRESSURE EVEN WHEN IT IS SET AT ITS MAXIMUM RANGE. A CLINICAL SITE INVESTIGATION WAS CONDUCTED. THE SIPAP WAS SET UP WITH THE SAME SETTINGS USED ON THE PATIENT AND A DEMO CIRCUIT. NO ISSUES WERE NOTED. THE DEMO CIRCUIT WAS REMOVED AND THE PATIENT CIRCUIT WAS PLACED ON THE MACHINE. THE INVESTIGATORS WERE EXPECTING THE OUTCOME OF HIGH PRESSURE, BUT AGAIN THERE WAS A FAILURE TO ACHIEVE A PRESSURE HIGH. WE WANT TO FORMALLY REPORT AN INCIDENT FOR THE INVESTIGATION INTO THE ROOT CAUSE OF THE FAILURE TO ACHIEVE A PRESSURE HIGH DURING SIPAP VENTILATION. THE ACTUAL CIRCUIT USED ON THE PATIENT AND TWO COMPARISON SAMPLES WILL BE SENT IN FOR INVESTIGATION TO DETERMINE IF IT IS AN END USER FAILURE OR A DEFECTIVE DISPOSABLE CIRCUIT. NOTHING SERIOUS HAPPENED IMMEDIATELY TO THE PATIENT, BUT DUE TO THE PATIENT¿S MEDICAL CONDITION THE PATIENT EXPIRED AFTER SIX DAYS ON (B)(6) ON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403360 PACKAGE ASSEMBLY,GENERATOR KIT W_RT132 CIRCUITS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BD GENERATOR KIT 150724

    Patients

    Seq Age Sex Outcome Treatment
    1 Death