BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 237224 · Received August 25, 1999

    Report

    Report Number
    1042431-1999-00015
    Date Received
    August 25, 1999
    Date of Event
    July 7, 1999
    Report Date
    August 25, 1999
    Manufacturer
    ALTHIN MEDICAL, INC.
    Product Code
    FKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALTHIN MEDICAL GMBH REPORTED AN INCIDENT AT PHV. BACKFILTRATION; PT WAS DISCONNECTED IMMEDIATELY. THE FLOW EQUALIZER VALVE DID NOT CLOSE CORRECTLY (OPEN, SHOULD HAVE BEEN CLOSED). PATIENT BECAUSE "PUMPED UP". THIS IS A PRELIMINARY REPORT. MORE INFO HAS BEEN REQUESTED CONCERNING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS SYSTEM 1000 FKP ALTHIN MEDICAL, INC. SYSTEM 1000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other