BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 1231094 · Received October 30, 2008

    Report

    Report Number
    8030665-2008-00046
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 30, 2008
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT WAS RECEIVED FROM A HEMODIALYSIS USER FACILITY. IT WAS LEARNED THAT THIS EVENT OCCURRED AFTER A PATIENT HAD UNDERGONE ONE AND ONE-HALF HOURS OF THEIR DIALYSIS TREATMENT, WHEN A STAFF MEMBER NOTICED BLOOD LOSS ON THE MACHINE AND ON THE FLOOR. THE STAFF MEMBER IMMEDIATELY WENT OVER TO THE PATIENT, AND SHUT THE MACHINE OFF. UPON CLOSER INSPECTION OF THIS EVENT, IT WAS NOTED THAT BLOOD WAS DRIPPING OUT OF THE VENOUS CHAMBER, AND THAT THE TOP CAP OF THE VENOUS CHAMBER WAS PARTIALLY OFF, ALLOWING BLOOD TO FLOW OUT OF THAT CHAMBER, AND DOWN ON THE MACHINE AND THE VENOUS BLOODLINE. THE STAFF WERE ABLE TO RETURN THE BLOOD THAT WAS CONTAINED WITHIN THE ARTERIAL BLOODLINE, ALONG WITH A NORMAL SALINE BOLUS, HOWEVER, THEY DID NOT RETURN THE BLOOD CONTAINED IN THE VENOUS LINE. THE FACILITY REPORTED THAT THE BLOOD LOSS WAS ESTIMATED TO BE 400 ML. A STAT HEMOGLOBIN WAS DRAWN AND THE RESULTS WERE REPORTED AS BEING STABLE. THE PATIENT WAS THEN RE-STARTED ON A NEW MACHINE AS WELL AS A NEW TREATMENT SET AND THE PATIENT DID RECEIVE THEIR COMPLETE TREATMENT WITHOUT FURTHER INCIDENCE. THE BLOODLINES HAVE BEEN SAVED FOR EVALUATION. REPORTEDLY, THIS PATIENT WAS DISCHARGED TO HOME WHEN THE TREATMENT WAS COMPLETED WITH NO FURTHER ILL EFFECT OR MEDICAL INTERVENTION RECEIVED TO DATE AS A RESULT FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 8ER238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA