BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 283279 · Received June 20, 2000

    Report

    Report Number
    8030665-2000-00193
    Event Type
    Injury
    Date Received
    June 20, 2000
    Date of Event
    May 20, 2000
    Report Date
    May 25, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPRESENTATIVE REPORTED THAT AN EVENT OCCURRED ON 5-2-00. TWO HOURS INTO TREATMENT, A VENOUS LINE SEPARATED FROM A CATHETER- MAKE UNKNOWN. THE PT'S ESTIMATED BLOOD LOSS WAS 100-150CC. THE MACHINE WAS A 2008H WITH NARROW LIMITS SOFWARE. THE MACHINE DID NOT ALARM. THE LINE WAS RECONNECTED AND THE PT CONTINUED TREATMENT WITHOUT FURTHER INCIDENT. THE SAMPLE WAS DISCARDED. THE CLINIC LATER REPORTED THAT THEY BELIEVE THE CONNECTION WAS NOT TIGHT. MDR FILED DUE TO BLOOD LOSS OF 100-150CC ONLY. NO PT ILL EFFECTS. FOLLOWUP MADE AT THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FKJ ERIKA DE REYNOSA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 2008H.