BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - HARDWARE

    MDR report key: 1849279 · Received September 30, 2010

    Report

    Report Number
    1423500-2010-03955
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 7, 2010
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE IS UNKNOWN AND THEREFORE THE 510(K) ENTRY FIELD IS LEFT BLANK. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS DETERMINED THAT THIS PRODUCT IS A DRUG AND NOT A DEVICE. THIS INCIDENT INVOLVING THE DISPOSABLE DEVICE WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 1423500-2010-03968.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT FROM (B)(6) WHO WAS UNDERGOING HEMODIALYSIS USING AN UNSPECIFIED HEMODIALYSIS SOLUTION AND WENT INTO FULL CARDIAC ARREST DURING LAST 8 MINUTES OF HEMODIALYSIS. PATIENT WAS HEARD TO HAVE DIFFICULTY BREATHING WHEN A STAFF MEMBER WENT OVER. THE PATIENT SUFFERED A LOSS OF CONSCIOUSNESS, CARDIOPULMONARY RESUSCITATION (CPR) COMMENCED, EMERGENCY RESPONDERS WERE PHONED, FULL RESUSCITATION WAS CONDUCTED WITH PARAMEDIC ASSISTANCE AND THE PATIENT LEFT UNIT UNRESPONSIVE IN THE CARE OF PARAMEDICS AND TRANSFERRED TO NEAREST HOSPITAL FOR FURTHER TREATMENT. PATIENT WAS NOT WELL OVER THE WEEKEND AND DID NOT DISCLOSE THIS PRIOR TO HEMODIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R