BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICART

    MDR report key: 3781987 · Received April 30, 2014

    Report

    Report Number
    9616023-2014-00005
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KPO
    PMA / PMN Number
    K013724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BICART PRODUCT INVOLVED IN THIS INCIDENT WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    LIMITED INFORMATION HAS BEEN PROVIDED FOR THIS EVENT OTHER THAN THE PATIENT HAD A CARDIAC HISTORY AND EXPERIENCED AN EPISODE DURING TREATMENT THAT RESULTED IN HOSPITALIZATION. THE CLINICIAN AT THE HOSPITAL STATES THAT THIS INCIDENT WAS NOT PRODUCT RELATED. THE BICART WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. BICART MODEL AND LOT NUMBER WAS NOT PROVIDED. THE PHOENIX MACHINE WAS INSPECTED AND DETERMINED TO BE OPERATING WITHIN SPECIFICATION. THE CARTRIDGE BLOOD LINE WAS NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260832 BICART DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO GAMBRO LUNDIA AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PHOENIX, CARTRIDGE BLOOD LINE