BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT

    MDR report key: 2180075 · Received July 27, 2011

    Report

    Report Number
    2015691-2011-15955
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    PMA / PMN Number
    K053609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED; IF THE DEVICE BECOMES AVAILABLE AND IS EVALUATED A SUPPLEMENTAL REPORT WILL BE GENERATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN A PATIENT DEATH WHILE OUR PRESEP CATHETER WAS IN USE. AS REPORTED, THE CATHETER HAD MIGRATED AT SOME POINT; HOWEVER, IT WAS INDICATED THAT THE PLACEMENT OF THE CATHETER WAS INITIALLY CONSIDERED GOOD. THE PATIENT WAS IN FOR BOWEL OBSTRUCTION. AFTER SURGERY, A PIC LINE WAS INSERTED, DESPITE TOUGH LINE NERVE BUNDLES. THE PRESEP CATHETER WAS PLACED FOR A CENTRAL LINE; IT SHOWED "GREAT BLOOD RETURN, PLACEMENT LOOKED GOOD, X-RAY TAKE - CATHETER WAS IN GOOD POSITION". THROUGH THE NIGHT THE PATIENT GREW SICKER, IT WAS NO LONGER POSSIBLE TO GET A BLOOD RETURN FROM ANY OF THE PORTS. IT WAS STATED THAT THERE WAS DISCUSSION AS TO WHETHER OR NOT THE CATHETER MIGRATED BUT NO DOCUMENTATION WAS PROVIDED. IT WAS SPECULATED BY THE NURSE THAT PERHAPS THERE WAS A "POCKET" IN THE VESSEL AND ALTHOUGH FLUIDS WERE GIVEN INITIALLY AND EVERYTHING APPEARED FINE, POSSIBLY THE "POCKETS" GOT BIGGER DURING THE NIGHT LEADING TO A CARDIAC TAMPONADE. THE PATIENT ARRESTED AT 6:00 AM AND DEMONSTRATED PEA (PULSELESS ELECTRICAL ACTIVITY). APPROXIMATELY 2 LITERS OF "WHITE IV FLUID" WAS DRAINED VIA A CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT CENTRAL VENOUS CATHETER DQE EDWARDS LIFESCIENCES, PR PRESEP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death