BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVACLEAR

    MDR report key: 2113387 · Received May 29, 2011

    Report

    Report Number
    MW5020837
    Event Type
    Injury
    Date Received
    May 29, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 29, 2011
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS ON DIFFERENT MACHINES ON THE SAME DAY NOTED DIALYSIS ALARM SOUNDING. ALARM SHOWED "BLOOD LEAK" MEANING THAT DIALYSATE TUBING TESTED POSITIVE FOR BLOOD OUTSIDE THE EXTRACORPOREAL SYSTEM. TREATMENT WAS IMMEDIATELY TERMINATED. HE WAS MOVED TO A DIFFERENT MACHINE WITH A NEW SET UP. PT #2 ALSO HAD INFILTRATE OF HIS FISTULA. HE WAS ALSO PLACED ON A DIFFERENT MACHINE WITH A NEW SET UP. BOTH PTS WERE DISCHARGED HOME. PT #2 RETURNED TO THE ED AND WAS ADMITTED WITH RASH AND DYSPHAGIA. THE NEXT MORNING HE HAD GROSS HEMATURIA. SYMPTOMS RESOLVED WITH TREATMENT AND PT WAS DISCHARGED HOME. DATES OF USE: (B)(6) 2011 TO DATE. ALSO SEE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVACLEAR NONE KDI C411200201

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization