BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX 210H

    MDR report key: 3894476 · Received June 25, 2014

    Report

    Report Number
    9611369-2014-00014
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POLYFLUX 210 H DIALYZER INVOLVED IN THE TREATMENT WAS DISCARDED AND NOT AVAILABLE FOR TECHNICAL INVESTIGATION. GAMBRO COULD NEITHER PERFORM A LOT HISTORY RECORD CHECK NOR A COMPLAINT HISTORY FILE CHECK AS THE LOT NUMBER IS UNKNOWN. NEITHER THE CATHETER NOR THE NEEDLELESS IV CONNECTOR ARE GAMBRO MANUFACTURERED, DISTRIBUTED OR LABELED PRODUCT.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING A DIALYSIS TREATMENT WHICH INCLUDED A LUER NEEDLELESS IV ACCESS DEVICE CONNECTED TO THE ARTERIAL CONNECTOR OF THE CATHETER. APPROXIMATELY 30 MINUTES INTO THE TREATMENT THE PATIENT COMPLAINED OF DISCOMFORT, MALAISE AND APPEARED CYANOTIC. THE NURSE OBSERVED AIR BUBBLES IN THE VENOUS BLOOD LINE BEFORE AND AFTER THE AIR DETECTOR. TREATMENT WAS STOPPED WITHOUT RETURNING THE BLOOD IN THE EXTRA CORPOREAL CIRCUIT RESULTING IN AN ESTIMATED BLOOD LOSS OF 120 ML. OXYGEN WAS ADMINISTERED AND THE PATIENT WAS PLACED IN A TRENDELENBERG POSITION. THE ARTERIAL CONNECTOR OF THE CATHETER WAS REPLACED AND TREATMENT RESTARTED. AT THE END OF THE SECOND TREATMENT THE PATIENT FELT MALAISE AGAIN, WITHOUT BEING HYPOTENSIVE. ACCORDING TO THE MEDICAL STAFF THE PATIENT HAD AN AIR EMBOLISM. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION FOR 24 HOURS AND THEN DISCHARGED HOME. LATER, A CRACK WAS FOUND IN THE ARTERIAL CONNECTOR OF THE CATHETER WHICH RESULTED IN THE INGRESSION OF AIR. BECAUSE OF THE POSITIONING OF THE NEEDLELESS IV ACCESS DEVICE, THE CRACK WAS NOT VISIBLE TO THE USER. FOLLOWING THE DISCOVERY OF THE CRACK, THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371991 POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 210 H UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization ARTIS PHYSIO, ARTISET HD DNL HC