BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ART PILLOW 8MM PUMP SEGM UNIVE

    MDR report key: 179503 · Received July 24, 1998

    Report

    Report Number
    8030665-1998-00834
    Event Type
    Malfunction
    Date Received
    July 24, 1998
    Date of Event
    June 17, 1998
    Report Date
    June 30, 1998
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REC'D NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM DIRECTOR OF NURSING. (DIRECTOR OF NURSING NOT AVAILABLE 6/30). SPOKE WITH RN WHO WAS COVERING CHARGE ON THE DAY OF THE EVENT. STATES JUST PRIOR TO REINFUSION, THE PUMP SEGMENT SEPARATED FROM THE PUMP SEGMENT CONNECTOR. THE END OF THE LINE BECAME CONTAMINATED AND THEY WERE UNABLE TO REINFUSE ALL OF THE SYSTEM. ESTIMATED BLOOD LOSS 50CC. PT STABLE THROUGHOUT EVENT, NO INTERVENTION REQUIRED. THIS WAS A 9TH USE FOR THIS LINE. THE LINE IS AVAILABLE FOR EVALUATION. A RESPONSE LETTER AND MAILER HAVE BEEN SENT TO THE FACILITY. THIS IS ONE OF TWO COMPLAINTS FROM THIS FACILITY. REFERENCE PIR#9801252. A MEDWATCH FORM HAS BEEN FILED BASED ON CO'S REPORTING REQUIREMENTS FOR BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART PILLOW 8MM PUMP SEGM UNIVE BLOOD LINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA NA R8C003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other FRESENIUS 2008H MACHINE, F6 DIALYZER, DIALYSIS 3X/| WEEK.