BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICART 1250G

    MDR report key: 1760872 · Received July 7, 2010

    Report

    Report Number
    9616026-2010-00007
    Event Type
    Injury
    Date Received
    July 7, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KPO
    PMA / PMN Number
    K013724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BICART INVOLVED IN THIS INCIDENT WAS RETAINED BY THE FACILITY AND WILL NOT BE RELEASED TO GAMBRO FOR INVESTIGATION. SINCE THE LOT NUMBER IS UNK, WE WILL IDENTIFY THE LOT NUMBERS RECENTLY SOLD TO THE CUSTOMER. THE COMPLAINT AND PRODUCTION HISTORY OF THESE LOT NUMBERS WILL BE ANALYZED. THE MEDICAL STAFF DOES NOT BELIEVE THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE PT HAD A CARDIAC ARREST ABOUT 1 1/2 HOURS INTO A HEMODIALYSIS TREATMENT. THE PT WAS SUCCESSFULLY RESUSCITATED AND TRANSPORTED TO THE HOSPITAL. THE CAUSE OF THE PT'S CARDIAC ARREST IS UNK. THE DISPOSABLES USED DURING TREATMENT HAVE BEEN RETAINED BY THE CLINIC AND WILL NOT BE RETURNED TO GAMBRO. THE MACHINE WAS INSPECTED BY A GAMBRO TECHNICAL SERVICE REP WHO FOUND IT TO BE FUNCTIONING CORRECTLY AND WITHIN MFR SPECS. THE MACHINE WAS RETURNED TO SERVICE CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICART 1250G DIALYSATE CONCENTRATE FOR HEMODIALYSIS KPO GAMBRO LUNDIA AB BICART 1250G UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R ACID CONCENTRATE ROCKWELL ACID| GAMBRO CARTRIDGE BLOOD SET, LOT # UNK.| REVACLEAR LOT NUMBER UNK.| PHOENIX MACHINE, (B)(4), SW 3.36.| FORMULA AND LOT # UNK