BEUDAMED
    FDA Adverse Event Death Summary report: N

    BICART

    MDR report key: 2006990 · Received February 23, 2011

    Report

    Report Number
    9616023-2011-00002
    Event Type
    Death
    Date Received
    February 23, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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 FACILITY. GAMBRO IDENTIFIED THE LOT NUMBER OF THE BICART SHIPPED TO THIS CUSTOMER PRIOR TO THIS EVENT AS LOT 05524. NO NONCONFORMITY HAS BEEN IDENTIFIED IN THE DEVICE HISTORY RECORD THAT IS RELATED TO THIS EVENT. GAMBRO RECEIVED NO INFORMATION TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    DURING A HEMODIALYSIS TREATMENT ON A (B)(4) MACHINE, THE PT CODED AND EXPIRED. THE MACHINE WAS INSPECTED BY GAMBRO TECHNICAL SPECIALIST REPRESENTATIVE WHO FOUND IT TO BE FUNCTIONING CORRECTLY AND WITHIN MANUFACTURER'S SPECIFICATIONS. THE DIALYSIS MACHINE WAS RETURNED TO CLINICAL USE. PER DCI CORPORATE POLICY, NO FURTHER PT, TREATMENT, OR DEVICE INFORMATION WILL BE PROVIDED. NEITHER THE PHYSICIAN, NOR THE NURSES CARING FOR THE PT, BELIEVES ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PT'S CARDIAC ARREST. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR WERE NOT AVAILABLE FOR INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death