BEUDAMED
    FDA Adverse Event Death Summary report: N

    8010182-2007-00008

    MDR report key: 910313 · Received September 6, 2007

    Report

    Report Number
    8010182-2007-00008
    Event Type
    Death
    Date Received
    September 6, 2007
    Product Code
    MQS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    TAKING INTO CONSIDERATION THE CLINICAL REPORT WE RECEIVED FROM OUR MEDICAL EXPERT, WE CAN HIGHLIGHT THE FOLLOWING POINTS: THE PT WAS SERIOUSLY ILL AND EXPECTED TO DIE BEFORE HIS CONNECTION TO THE PRISMAFLEX M100 SET. THE INTENSIVE CARE NURSE SUPERVISOR CONFIRMED THAT: PRISMAFLEX M100 SET HAS BEEN USED FROM THE SAME LOT ON DIFFERENT PTS, WITHOUT ANY INCIDENT. SHE DID NOT BELIEVE THAT THE PRISMAFLEX M100 CONTRIBUTED TO THE PT DEATH. WE CONSIDER THE DEVICE NOT BE AT THE ORIGIN OF THIS INCIDENT THAT REMAINS EXCEPTIONAL. NO FURTHER ACTION WILL BE TAKEN BY GAMBRO INDUSTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MQS

    Patients

    Seq Age Sex Outcome Treatment
    1