BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW VOLUME W/ BVM BLOODLINE

    MDR report key: 2210382 · Received August 8, 2011

    Report

    Report Number
    8030665-2011-00044
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    March 22, 2011
    Report Date
    August 9, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K001107
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A (B)(4) HEMODIALYSIS FACILITY REPORTED THAT A PT WAS ON DIALYSIS FOR 1 HOUR WHEN SHE DEVELOPED ABDOMEN PAIN, HYPERTENSION, AND BLOODY URINE. THE ARTERIAL TUBING WAS KINKED BETWEEN BLOOD PUMP AND DIALYZER AND WAS UNABLE TO BE STRAIGHTENED DUE TO TUBING LENGTH AND HEIGHT OF THE HOLDER FOR THE DIALYZER. THE PT'S TREATMENT WAS STOPPED AND THE PT WAS OBSERVED IN THE HOSPITAL FOR 3 DAYS. IT WAS REPORTED THAT THE PT HAS RECOVERED. THE SAMPLE IS AVAILABLE. OF NOTE: ADDITIONAL INFO HAS BEEN REQUESTED, HOWEVER NO FURTHER INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW VOLUME W/ BVM BLOODLINE HEMODIALYSIS BLOODLINE FJK REYNOSA MANUFACTURING NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| O| R