BEUDAMED
    FDA Adverse Event Death Summary report: N

    BICART 720G

    MDR report key: 2040780 · Received March 30, 2011

    Report

    Report Number
    9616023-2011-00004
    Event Type
    Death
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    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 NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER COULD NOT BE PROVIDED BY THE FACILITY. GAMBRO HAS IDENTIFIED THE LOT NUMBERS OF THE BICART PRODUCTS SHIPPED TO THIS CUSTOMER PRIOR TO THIS EVENT AS LOT 5436 AND 5551. NO NONCONFORMITY HAS BEEN IDENTIFIED IN THE DEVICE HISTORY RECORD FOR THESE LOT NUMBERS. GAMBRO REC'D NO INFO TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    AN ADULT PT CODED AND EXPIRED SHORTLY AFTER ENDING AN IN-PT HEMODIALYSIS TREATMENT. DURING THE HEMODIALYSIS TREATMENT PT DID NOT FEEL WELL AND THE TREATMENT WAS TERMINATED. PER DCI CORPORATE POLICY, NO FURTHER PT TREATMENT, OR DEVICE INFO WILL BE PROVIDED. GAMBRO DIALYSIS MACHINE WAS INSPECTED AND WAS FOUND WITHIN MFR SPECIFICATION. NEITHER THE PHYSICIAN, NOR THE NURSES CARING FOR THE PT, BELIEVES THAT ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PT'S CODING EVENT AFTER DIALYSIS HAD BEEN COMPLETED. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR DIALYZER WERE NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BICART 720G KPO GAMBRO LUNDIA AB BICART 720G UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BICART (UNK LOT)| CARTRIDGE BLOOD TUBING SET (UNK LOT)| REVACLEAR (UNK LOT)