BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS

    MDR report key: 3915463 · Received February 25, 2014

    Report

    Report Number
    2937457-2014-00286
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 29, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    ONW
    PMA / PMN Number
    K070049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS TO DATE INDICATED THE REPORTED MALFUNCTION OCCURRED DURING RECIRCULATION AND PRIME (MACHINE SET-UP), AND NOT DURING DIALYSIS MODE. THE USER VISUALLY OBSERVED THE SALINE BAG REFILLING AND SUSPECTED DIALYSATE INTRUSION DURING CIRCULATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE. THE REPORT IS BEING INVESTIGATED BY THE MANUFACTURER VIA A CAPA. THE INVESTIGATION IS PENDING, A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A BIOMEDICAL TECHNICIAN REPORTED THAT USER DISCOVERED THE SALINE BAG WAS TOO FULL WHILE A PATIENT WAS BEING DIALYZED. THE NURSE REPORTED THAT THE PATIENT WAS BROUGHT IN FOR DIALYSIS IN BED. THE PATIENT WAS NOT AWARE OF THE SURROUNDINGS. THE MACHINE WAS TAKEN OUT OF RECIRCULATION MODE. BEFORE THE PATIENT WAS CONNECTED THE SALINE BAG WAS DOUBLE CLAMPED. THE PATIENT WAS HOOKED UP FOR DIALYSIS AND WAS NO TREATMENT FOR 30 MINUTES BEFORE THE NURSE NOTED THAT THE SALINE BAG WAS MORE FULL THAN IT SHOULD BE. THE NURSE CALLED THE BIOMED TECHNICIAN AND WAS INFORMED THAT THE PATIENT SHOULD BE DISCONNECTED. THE NURSE STOPPED TREATMENT AND DISCONNECTED THE PATIENT WITHOUT USING THE SALINE BAG TO FLUSH THE BLOOD LINE. THE NURSE DID NOT EXPERIENCE ANY ADVERSE EVENT AND WAS NOT EXPOSED TO THE SALINE. NO TREATMENT WAS NECESSARY FOR THE MINOR BLOOD LOSS. THE PATIENT WAS TAKEN TO ANOTHER HEMODIALYSIS MACHINE TO FINISH TREATMENT AND THE AFFECTED MACHINE WAS TAKEN OUT OF SERVICE. ON SITE BIOMED TECHNICIAN REPLACED VALVE 30. SINCE THE REPAIR THE SYSTEM WAS PLACED BACK IN USE WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116107 2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS ONW FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR UNK SALINE (DISCARDED - NOT USED)