BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX REVACLEAR DIALYZER

    MDR report key: 1616540 · Received February 24, 2010

    Report

    Report Number
    3006552611-2010-00001
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 26, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS INC.
    Product Code
    KDI
    PMA / PMN Number
    K072232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PRODUCT IN USE AT THE TIME OF THE EVENT IS UNK. THE LAST SHIPMENT TO THE CLINIC INCLUDED THE LOT NUMBER C409110501; TWO DEVICES FROM THE SAME LOT NUMBER WERE EVALUATED. CHEMICAL TESTING WAS PERFORMED ACCORDING TO QUALITY ASSURANCE PROCEDURES AND BOTH DEVICES PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IMMEDIATELY UPON INITIATING HEMODIALYSIS, THE PT BECAME HYPOTENSIVE AND UNRESPONSIVE; A CODE WAS CALLED AND CPR STARTED. TREATMENT WAS STOPPED WITHOUT RETURNING THE PT'S BLOOD. THE PT RECEIVED A BOLUS OF 500 ML OF SALINE; HIS BP INCREASED AND HE BECAME RESPONSIVE. NO OTHER MEDICATIONS WERE ADMINISTERED AND THE PT WAS TRANSFERRED TO ICU FOR FURTHER MONITORING. THIS WAS THE PT'S 8TH HEMODIALYSIS TREATMENT; HE HAD A REACTION PRIOR TO THIS EVENT DURING THE 7TH TREATMENT. THE PT HAS BEEN SWITCHED TO A GAMMA-STERILIZED DIALYZER CONTAINING A CELLULOSE DIACETATE MEMBRANE AND HAS HAD NO FURTHER EVENTS. THE PHYSICIAN CARING FOR THE PT HAS CONCLUDED THAT THE PT EXPERIENCED TYPE 1 DIALYZER REACTION TO THE GAMBRO POLYFLUX REVACLEAR DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX REVACLEAR DIALYZER KDI GAMBRO RENAL PRODUCTS INC. C409110501

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R