BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBI-SET FOR FRES2008 8MM POST PUMP

    MDR report key: 231208 · Received July 5, 1999

    Report

    Report Number
    8030665-1999-00209
    Event Type
    Malfunction
    Date Received
    July 5, 1999
    Date of Event
    April 23, 1999
    Report Date
    June 14, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CHIEF TECHNICIAN AT CLINIC THAT DURING TREATMENT THE AIR DETECTER ALARMED. UPON EXAMINATION OF THE TUBING IT WAS FOUND THAT THERE WAS A SMALL HOLE AROUND THE SEAL AT THE BOTTOM OF THE ARTERIAL CHAMBER WHICH ALLOWED AIR TO ENTER SYSTEM. THE TUBING WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. THE ESTIMATED BLOOD LOSS WAS 100<CC. NO ADVERSE EFFECTS OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS MD DOB 8-17-49. MDR FILED DUE TO BLOOD LOSS ONLY. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBI-SET FOR FRES2008 8MM POST PUMP BLOODLINE FJK ERIKA DE REYNOSA NA R8K091

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other FRESENIUS 2008H,| F70NR DIALYZERS.