BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICART 720G

    MDR report key: 1971418 · Received January 24, 2011

    Report

    Report Number
    9616023-2011-00001
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GAMBRO RECEIVED NO INFO AND LEARNED NOTHING FROM ITS INSPECTION OF THE PHOENIX DEVICE TO SUGGEST THAT ANY GAMBRO PRODUCT HAD MALFUNCTIONED OR OTHERWISE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE BICART INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED BY THE FACILITY. GAMBRO IDENTIFIED THE LOT NUMBER OF THE BICART SHIPPED TO THIS CUSTOMER PRIOR TO THIS EVENT AS LOT 05389, 05427 AND 05436. NOTHING IN THE DEVICE HISTORY RECORD SHOWS OF ANY NONCONFORMITY AND THERE ARE NO CUSTOMER EVENTS REFERRING TO THIS LOT NUMBER.

    Description of Event or Problem · 1

    FOLLOWING AN UNEVENTFUL HEMODIALYSIS TREATMENT ON A PHOENIX MACHINE, THE PT HAD A CARDIAC ARREST. 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 INFO WILL BE PROVIDED. NEITHER THE PHYSICIAN, NOR THE NURSES CARING FOR THE PT, BELIEVE ANY GAMBRO DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S CARDIAC ARREST. THE CARTRIDGE BLOOD SET, BICART AND REVACLEAR WERE REPORTED NOT AVAILABLE FOR INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PHOENIX MACHINE, (B)(4)| GAMBRO CARTRIDGE BLOOD SET, LOT NUMBER UNK| REVACLEAR, LOT NUMBER UNK