BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 7070476 · Received November 30, 2017

    Report

    Report Number
    9680904-2017-00225
    Event Type
    Death
    Date Received
    November 30, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 27, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    K112851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP SUBMISSION WILL BE DONE IF ADDITIONAL INFORMATION BECOMES AVAILABLE. NO DEVICE OR LOT PROVIDED.

    Description of Event or Problem · 1

    COMMENTS BELOW ARE BASED ON CONVERSATIONS WITH THE ONCOLOGY WARD NUM AND CNC: * PALLIATIVE PATIENT WAS SENT TO WARD WITH A DEFLATED LUNG AFTER HAVING HAD PLEURX INSERTED. UNKNOWN CAUSE OF DEFLATED LUNG. * NOTES TO NURSING STAFF WERE TO USE PLEURX TO REINFLATE THE LUNG.THIS IS NOT IN THE DFU. * IMMEDIATELY AFTER PLEURX BOTTLE SUCTION WAS APPLIED (T-PLUNGER WAS PUSHED DOWN AND ROLLER PLUNGER WAS ROLLED IN MOST OPEN POSITION) THE PATIENT WENT INTO CARDIAC ARREST. * THE PATIENT WAS A DNR BUT A CODE WAS CALLED. RESUSCITATION EFFORTS WERE NOT SUCCESSFUL. * THE CLINICIANS AND DOCTOR DO NOT BELIEVE IT WAS THE PLEURX THAT CAUSED THE DEATH. WAITING FOR CALL BACK FROM THE DOCTORS INVOLVED FOR MORE DETAILS. ON 07NOV2017- ADDITIONAL INFORMATION/CLARIFICATION EMAILED TO RCC. ON 23NOV2017 ADDITIONAL INFORMATION RECEIVED FROM OUS RCC: (B)(6), A NURSE I SPOKE TO AT (B)(6) (WHERE THE PLEURX WAS INSERTED) WAS NOT AWARE OF ANY DEFLATED LUNG. THIS CONTRADICTS WHAT THE ONCOLOGY CNC HAS TOLD ME. I AM AWAITING A CALL THIS AFTERNOON FROM THE NUM OF (B)(6) WHO WAS THERE FOR THE PLEURX INSERTION TO PROVIDE GREATER CLARITY. FURTHER DETAILS DISCOVERED FROM YESTERDAY: ¿ 1L OF FLUID WAS REMOVED FROM THE PLEURX PRIOR TO THE PATIENT BEING TRANSPORTED TO THE WARD. PATIENT WAS SENT TO WARD TO WAIT FOR A X-RAY OF THE LUNG TO CONFIRM PLEURX POSITIONING. PATIENT PASSED AWAY BEFORE X-RAY COULD BE PREFORMED. ¿ THE PATIENT WAS PRESENTING TO (B)(6) WEEKLY FOR >12 MONTHS WITH PLEURAL EFFUSIONS. ¿ DID NOT APPEAR TO BE AN ISSUE WITH THE BOTTLE.NO LOT NUMBERS ARE AVAILABLE FOR THE BOTTLE. ¿ THE NUM OF (B)(6) MAY BE ABLE TO PROVIDE A LOT NUMBER FOR THE INSERTION KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851222 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death