BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 3422718 · Received October 22, 2013

    Report

    Report Number
    8010182-2013-00008
    Event Type
    Injury
    Date Received
    October 22, 2013
    Date of Event
    September 7, 2013
    Report Date
    September 23, 2013
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX M100 FILTER SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION BY GAMBRO INDUSTRIES. THE PRISMAFLEX MACHINE WAS INSPECTED AND DETERMINED TO WORK ACCORDING TO SPECIFICATIONS. THE REVIEW OF THE PRISMAFLEX M100 FILTER SET DEVICE HISTORY RECORD FOR LOT NUMBER 13E0305G AND THE COMPLAINT HISTORY FILES CONFIRM THERE WERE NO NONCONFORMITIES AND NO OTHER COMPLAINT REPORTED REGARDING THIS LOT NUMBER. GAMBRO RECEIVED NO INFORMATION TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A CRITICALLY ILL PATIENT IN (B)(6) WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY. FOLLOWING THE CHANGE OF A SOLUTION BAG, THE MACHINE GENERATED THE ¿AIR IN BLOOD¿ ALARM. THE NURSE OBSERVED AIR IN THE EXTRACORPOREAL CIRCUIT THAT REACHED THE PATIENT¿S ACCESS. THE PATIENT BECAME HYPOTENSIVE AND REQUIRED AN INCREASE IN OXYGEN AND AN INCREASE IN PRESSOR SUPPORT. AN ECHOCARDIOGRAPHY CONFIRMED THE PRESENCE OF AIR IN THE RIGHT SIDE OF THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540490 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 106697 13E0305G

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening PRISMAFLEX MONITOR SN PA8082 SWV 6.10 ROW