BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIDECO ELECTA

    MDR report key: 4332719 · Received December 5, 2014

    Report

    Report Number
    1718850-2014-00462
    Event Type
    Other
    Date Received
    December 5, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 7, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IDENTIFIER AND WEIGHT WERE NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE DIDECO ELECTA. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(6) RECEIVED A REPORT THAT, AFTER BEING GIVEN 2 UNITS OF BANK BLOOD AS WELL AS A SMALL AMOUNT OF BLOOD WHICH WAS PROCESSED USING THE ELECTA AUTOTRANSFUSION DEVICE, THE PATIENT DEVELOPED RENAL INSUFFICIENCY RESULTING IN HEMOGLOBINURIA, ANURIA, ACUTE KIDNEY INJURY AND HYPERKALEMIA. AFTER 48 HOURS OF CONTINUOUS OBSERVATION, THE PATIENT WAS RELEASED WITH NO PERMANENT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER BEING GIVEN 2 UNITS OF BANK BLOOD AS WELL AS A SMALL AMOUNT OF BLOOD WHICH WAS PROCESSED USING THE ELECTA AUTOTRANSFUSION DEVICE, THE PATIENT DEVELOPED RENAL INSUFFICIENCY RESULTING IN HEMOGLOBINURIA, ANURIA, ACUTE KIDNEY INJURY AND HYPERKALEMIA. AFTER 48 HOURS OF CONTINUOUS OBSERVATION, THE PATIENT WAS RELEASED WITH NO PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786136 DIDECO ELECTA APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP DEUTSCHLAND 75205

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR