BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO AVF SET

    MDR report key: 225822 · Received May 28, 1999

    Report

    Report Number
    1118880-1999-00027
    Event Type
    Malfunction
    Date Received
    May 28, 1999
    Date of Event
    April 27, 1999
    Report Date
    April 29, 1999
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FIE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROX 3 HOURS AND 45 MINUTES INTO A DIALYSIS TREATMENT, A MONITOR ON THE DIALYSIS MACHINE DETECTED AIR IN THE BLOODLINE AND INITIATED AN ALARM. THE ATTENDING NURSE STOPPED THE TREATMENT, ASSESSED THE SITUATION AND DETERMINED THAT IT WAS SAFE TO RETURN THE BLOOD IN THE REMAINDER OF THE CIRCUIT TO THE PT. THE NURSE REPORTED THAT UPON EXAMINATION SHE OBSERVED A CRACK IN THE FEMALE LUER HUB THAT CONNECTS THE AVF NEEDLE SET TO THE BLOODLINE. SHE STATED IN HER REPORT THAT THE CRACK HAD NOT BEEN THERE WHEN THE TREATMENT WAS STARTED, OR THROUGHOUT THE TREATMENT UNTIL THIS TIME. THE NURSE REPORTED THAT THE PT WAS NOT AFFECTED BY THIS EVENT. HIS VITAL SIGNS WERE REPORTED TO BE STABLE AND HE WAS SENT HOME FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO AVF SET AV FISTULA NEEDLE SET FIE TERUMO MEDICAL CORP. NA XD18

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention MEDISYSTEMS BLOODLINE