BEUDAMED
    FDA Adverse Event Other Summary report: N

    745E225 KIT ATS X ELECTA

    MDR report key: 4379347 · Received December 19, 2014

    Report

    Report Number
    1718850-2014-00485
    Event Type
    Other
    Date Received
    December 19, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT WERE NOT PROVIDED. SORIN GROUP (B)(6) MANUFACTURES THE (B)(4) KIT ATS X ELECTA. THIS KIT IS NOT SOLD IN THE UNITED STATES BUT IS SIMILAR TO ANOTHER KIT (CATALOG # 04165M) WHICH IS DISTRIBUTED IN THE UNITED STATES, UNDER 510(K) NUMBER (B)(4). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, AFTER BEING GIVEN BLOOD WHICH WAS PROCESSED USING THE ELECTRA AUTOTRANSFUSION SYSTEM, 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)(6) RECEIVED A REPORT THAT, AFTER BEING GIVEN BLOOD WHICH WAS PROCESSED USING THE ELECTA AUTOTRANSFUSION SYSTEM, 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
    837393 745E225 KIT ATS X ELECTA APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA NA 1407160016

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other