BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX 170H

    MDR report key: 4160052 · Received October 10, 2014

    Report

    Report Number
    9611369-2014-00024
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 9, 2014
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIALYZER WAS DISCARDED AND NOT AVAILABLE FOR TECHNICAL INVESTIGATION. GAMBRO HAS FOUND NO EVIDENCE TO SUGGEST THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY. DIALYZER DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    GAMBRO LEARNED A PATIENT IN (B)(6) WAS UNDERGOING A DIALYSIS TREATMENT THAT INVOLVED A POLYFLUX 170 H DIALYZER. APPROXIMATELY 31/2 HOURS INTO TREATMENT THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN. THE NURSE OBSERVED A KINK IN THE ARTERIAL LINE AT THE TOP OF THE DIALYZER. THE KINK WAS CAUSED BY TRACTION ON THE ARTERIAL BLOODLINE BY THE OUTLET DIALYSATE HOSE. TREATMENT WAS DISCONTINUED WITHOUT RETURNING THE BLOOD IN THE EXTRACORPOREAL CIRCUIT RESULTING IN AN APPROXIMATE BLOOD LOSS OF 246 ML. THE PATIENT WAS NOT SYMPTOMATIC AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WAS HOSPITALIZED SOMETIME LATER AND DIAGNOSED WITH HEMOLYSIS. THE LAB WORK INDICATES THE HEMOLYSIS WAS NEITHER DRUG RELATED NOR MEDICALLY INDUCED. THE MOST PLAUSIBLE CAUSE OF THE HEMOLYSIS RELATES TO THE KINK IN THE ARTERIAL BLOOD LINE. THE DIALYZER WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637508 POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 170 H UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization BL10-E2AP-PL BLOOD LINE