BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SC+ HAEMODIALYSIS DEVICE

    MDR report key: 17982515 · Received October 23, 2023

    Report

    Report Number
    3013536188-2023-00008
    Event Type
    Injury
    Date Received
    October 23, 2023
    Date of Event
    January 25, 2023
    Report Date
    October 23, 2023
    Manufacturer
    QUANTA DIALYSIS TECHNOLOGIES LTD
    Product Code
    KDI
    PMA / PMN Number
    K210661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AGAIN TO FDA DUE TO RECEIVING EMAIL REPORT FROM FDA INDICATING ORIGINAL REPORT HAD INVALID MFR NUMBER. THE ORIGINAL REPORT NUMBER WAS 0000000-2023-09001. THE INFORMATION PROVIDED IN THIS REPORT IS SIMILAR TO REPORT 0000000-2023-09001. (B)(4). AS PART OF THE SC+ SAFETY SYSTEM THE DEVICE INCORPORATES AN AIR IN BLOOD SENSOR WHICH, IF ACTIVATED BY THE PRESENCE OF AIR IN THE EXTRACORPOREAL CIRCUIT, TRIGGERS THE MACHINE TO STOP THE BLOOD PUMP TO PREVENT AIR BEING PUSHED INTO THE PATIENT. THE PATIENT/USER IS ALERTED BY A WARNING MESSAGE ON THE SCREEN AND AUDIBLE ALARM THAT AIR HAS BEEN DETECTED. A REVIEW OF THE TREATMENT DATA FROM THE MACHINE SHOWS THAT AIR IN BLOOD SAFETY SYSTEM PASSED SELF CHECK AT THE START OF TREATMENT AND NO AIR WAS DETECTED IN THE LINES DURING THE TREATMENT. IF, AT ANYTIME, THE PATIENT DISCONNECTS THEIR CATHETER FROM THE BLOOD TUBE SET THEY ARE REQUIRED TO CLAMP THE CATHETER CLOSED TO ENSURE AIR IS NOT DRAWN INTO THE CATHETER AND SUBSEQUENTLY THE BODY. QUANTA IS TRYING TO ASCERTAIN FROM SPEAKING TO THE HOSPITAL IF THE PATIENT DISCONNECTED THE CANNULA AT ANY TIME DURING TREATMENT AND WHETHER USE ERROR MEANT THEY DID NOT CLOSE THE CLAMP OF THEIR CATHETER WHEN THEY DID THIS. PRESENTLY, THERE IS NO EVIDENCE TO SUGGEST MALFUNCTION IN THE SC+ LED TO THIS EVENT BUT WE CONTINUE TO WORK WITH THE CLINIC TO UNDERSTAND THE ROOT CAUSE OF THE INCIDENT AND WHETHER THE SC+ MAY HAVE CONTRIBUTED IN ANY WAY TO THE EVENT OCCURRING. QUANTA WILL PROVIDE FDA WITH A FOLLOW-UP REPORT OF OUR INVESTIGATION. MOREOVER, DUE TO THE INCIDENT OCCURRING IN THE UNITED KINGDOM QUANTA HAS REPORTED INCIDENT TO MHRA ((B)(4)).

    Description of Event or Problem · 0

    QUANTA DIALYSIS TECHNOLOGY RECEIVED AN ADVERSE EVENT REPORT ON (B)(6), 2023. THE INCIDENT OCCURRED ON (B)(6), 2023 AT (B)(6) HOSPITAL IN LONDON, UNITED KINGDOM. THE CLINIC REPORTED THAT, FOLLOWING DIALYSIS TREATMENT A FEMALE PATIENT BECAME UNRESPONSIVE. FOLLOWING CT SCANS THE HOSPITAL CONFIRMED THAT THE PATIENT HAD SUFFERED FROM AN AIR EMBOLISM. IT WAS REPORTED THAT THE PATIENT CONNECTED THEIR VENOUS LINE TO THE SALINE LINE AND COMMENCED WASHBACK/RINSEBACK. AFTER COMPLETING FULL WASHBACK/RINSEBACK (I.E. AFTER RETURNING ALL THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT INTO THE BODY), THE PATIENT HAD REPORTED TO A CLINICIAN THAT SHE FELT DIZZY AND UNWELL. THE PATIENT BECAME UNRESPONSIVE AND A NURSE ADMINISTERED GELOFUSINE TO THE PATIENT AND CPR WAS PERFORMED. THE PATIENT WAS TAKEN INTO INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985820 SC+ HAEMODIALYSIS DEVICE SC+ KDI QUANTA DIALYSIS TECHNOLOGIES LTD SC-12410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization