BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX 14L

    MDR report key: 4092604 · Received September 16, 2014

    Report

    Report Number
    9611369-2014-00021
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 16, 2014
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIALYZER WAS DISCARDED AND NOT AVAILABLE FOR TECHNICAL INVESTIGATION. GAMBRO PERFORMED A LOT HISTORY RECORD CHECK. THIS LOT WAS PRODUCED AND TESTED WITHOUT ANY NONCONFORMITIES. THERE WERE 38.880 DIALYZERS PRODUCED AND DISTRIBUTED FROM THIS LOT NUMBER. WE HAVE RECEIVED NO REPORTS OF ANY SIMILAR ISSUES WITH REGARD TO ANY OTHER DIALYZERS FROM THAT LOT.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING A DIALYSIS TREATMENT THAT INCLUDED A POLYFLUX 14 L DIALYZER. WITHIN TEN MINUTES OF INITIATING TREATMENT, BLOOD WAS OBSERVED LEAKING FROM THE END CAP OF THE DIALYZER. THERE WAS AN APPROXIMATE BLOOD LOSS OF 250 ¿ 300 ML WHEN THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT. TREATMENT CONTINUED WITH A NEW DIALYZER AND BLOOD LINE SET. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE BLOOD LOSS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571004 POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 14L APAC 3-5274-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other