BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM ROLLER PUMP

    MDR report key: 17719366 · Received September 11, 2023

    Report

    Report Number
    3006073153-2023-00002
    Event Type
    Death
    Date Received
    September 11, 2023
    Report Date
    August 9, 2023
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DTQ
    PMA / PMN Number
    K173834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS AN ACCIDENTAL MISTAKE DUE TO HUMAN ERROR. DISPOSABLE TUBING WAS LOADED IN THE OPPOSITE WAY IN THE ROLLER PUMP AND WAS NOT TESTED BEFORE USE. THE EVENT WAS NOT CAUSED BY ANY PRODUCT DEFECT OR MISSING RISK CONTROLS.

    Description of Event or Problem · 0

    CHIEF PERFUSIONIST DESCRIBES THE SITUATION DURING A PHONE CALL ON (B)(6) AS FOLLOWS: COMPLICATED, LONG, DYNAMIC AORTIC CASE. TEAM EXHAUSTED. EXTERNAL SURGEON RUNNING THE CASE IS USED TO DIFFERENT PROTOCOLS THAN THE ONES LOCALLY USED. DURING THE CASE AN ADDITIONAL SUCKER WAS REQUESTED. THE PERFUSIONIST MOUNTED THE ADDITIONAL SUCKER INTO AN EXISTING EXTRA-PUMP ON THE CHELTENHAM FRAME. UNFORTUNATELY THE TUBE WAS INSERTED INTO THE RACEWAY THE WRONG WAY ROUND. THE SURGEON DID NOT TEST THE SUCKER, INSERTED INTO AN AORTIC GRAFT AND ORDERED TO START THE SUCTION. AIR WAS PUMPED INTO THE PATIENT WHO UNFORTUNATELY DID NOT SURVIVE THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146744 QUANTUM ROLLER PUMP ROLLER PUMP DTQ SPECTRUM MEDICAL LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death