BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIEZOLITH

    MDR report key: 6208327 · Received December 28, 2016

    Report

    Report Number
    6208327
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 21, 2016
    Manufacturer
    UNITED MEDICAL SYSTEMS DE, INC.
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ELECTIVE LITHOTRIPSY DONE. PT WAS UNABLE TO AMBULATE POST PROCEDURE AND WAS SENT TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. PT BECAME HYPOTENSIVE AND A CAT SCAN REVEALED A LARGE RETROPERITONEAL HEMATOMA AND GRADE FIVE LEFT KIDNEY LACERATION. PT WAS TAKEN TO IR (INTERVENTIONAL RADIOLOGY) TO FIND AND EMBOLIZE THE SOURCE OF THE BLEEDING. THE KIDNEY WAS IN SHOCK AND WAS NOT GETTING BLOOD FLOW. DURING THE COURSE OF THE NEXT TWENTY-FOUR HOURS, THE PT CONTINUED TO BLEED FROM AN UNKNOWN SOURCE. PT. WENT INTO SHOCK, DIC, AND PASSED AWAY TWO DAYS LATER FOLLOWING THE ELECTIVE LITHOTRIPSY. THIS INVESTIGATION IS ONGOING. WE DO NOT HAVE ALL THE NECESSARY PAPERWORK FROM THE LOCAL VENDOR AS THIS MACHINE IS A CONTRACTED PIECE OF EQUIPMENT. WE ARE STILL AWAITING RECORDS IN REGARDS TO THE REPAIR HISTORY AND/OR CALIBRATION HISTORY. IT IS TO BE NOTED THAT THIS MACHINE WAS USED ON SIX PATIENTS AFTER THIS ONE ON THAT DAY WITHOUT ISSUE THAT WE ARE AWARE OF AT THIS PRESENT TIME. WE CONDUCTED OUR INVESTIGATION INTO THE EVENT INVOLVING THE LITHOTRIPSY TABLE, AND WE FOUND THAT THE TABLE WAS NOT THE CAUSE OF THE EVENT AND WAS IN CORRECT WORKING ORDER WHEN THIS HAPPENED. THE PATIENT'S MULTIPLE CO-MORBIDITIES WERE DEEMED THE CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    PT HAD ELECTIVE LITHOTRIPSY DONE. PT WAS UNABLE TO AMBULATE POST PROCEDURE AND WAS SENT TO THE EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. PT BECAME HYPOTENSIVE AND A CAT SCAN REVEALED A LARGE RETROPERITONEAL HEMATOMA AND GRADE FIVE LEFT KIDNEY LACERATION. PT WAS TAKEN TO IR (INTERVENTIONAL RADIOLOGY) TO FIND AND EMBOLIZE THE SOURCE OF THE BLEEDING. THE KIDNEY WAS IN SHOCK AND WAS NOT GETTING BLOOD FLOW. DURING THE COURSE OF THE NEXT TWENTY-FOUR HOURS, THE PT CONTINUED TO BLEED FROM AN UNKNOWN SOURCE. PT. WENT INTO SHOCK, DIC, AND PASSED AWAY TWO DAYS LATER FOLLOWING THE ELECTIVE LITHOTRIPSY. THIS INVESTIGATION IS ONGOING. WE DO NOT HAVE ALL THE NECESSARY PAPERWORK FROM THE LOCAL VENDOR AS THIS MACHINE IS A CONTRACTED PIECE OF EQUIPMENT. WE ARE STILL AWAITING RECORDS IN REGARDS TO THE REPAIR HISTORY AND/OR CALIBRATION HISTORY. IT IS TO BE NOTED THAT THIS MACHINE WAS USED ON SIX PATIENTS AFTER THIS ONE ON THAT DAY WITHOUT ISSUE THAT WE ARE AWARE OF AT THIS PRESENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859734 PIEZOLITH LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE LNS UNITED MEDICAL SYSTEMS DE, INC. 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R PT WAS UNDER MODERATE SEDATION. PT HAD RENAL STEN| PT WAS UNDER MODERATE SEDATION. PT HAD RENAL STEN