BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX L CAPILLARY DIALYZER

    MDR report key: 2162081 · Received July 12, 2011

    Report

    Report Number
    9611369-2011-00001
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K040255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO POLYFLUX 21 L DIALYZER WAS USED IN THE DIALYSIS TREATMENT. THE POLYFLUX 21 L SAMPLE INVESTIGATION COULD NOT BE PERFORMED DUE TO MASSIVE CLOTTING OF RESIDUAL BLOOD IN THE USED SAMPLE. GAMBRO PERFORMED A LOT HISTORY RECORD CHECK. THIS LOT WAS PRODUCED AND TESTED WITHOUT ANY CONSPICUITY. (B)(4). GAMBRO PERFORMED A COMPLAINT HISTORY FILE CHECK. NO FURTHER COMPLAINTS WERE REPORTED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    AT THE END OF A 4 HOUR DIALYSIS TREATMENT, THE PATIENT COMPLAINED OF NOT FEELING WELL WITH INTERMITTENT ABDOMINAL PAIN, BACK PAIN AND NAUSEA. THE PATIENT'S BP INCREASED FROM 190/111 MMHG AT START OF TREATMENT TO 223/119 MMHG. A MINOR KINK/MARK WAS OBSERVED IN THE ARTERIAL BLOOD LINE BETWEEN THE BLOOD PUMP AND THE DIALYZER INLET. TREATMENT WAS TERMINATED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD TO THE PATIENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION RELATED TO HEMOLYSIS. THE PATIENT'S CONDITION IMPROVED WITHIN 2 HOURS; THERE WAS NO MEDICAL INTERVENTION OR BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX L CAPILLARY DIALYZER KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 21 L 1-6029-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization BLOOD TUBING SET, BL207B LOT# 1111| ACID CONCENTRATE, D 781| BICART, LOT# UNKOWN| MONITOR, AK 200 S