BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMCATH

    MDR report key: 4869821 · Received June 25, 2015

    Report

    Report Number
    3004367028-2015-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 18, 2015
    Report Date
    June 25, 2015
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K040301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GAM CATH INVOLVED IN THIS EVENT WAS NOT AVAILABLE FOR A TECHNICAL INVESTIGATION. RETAINED SAMPLE OF THE ASSEMBLED CLAMP LOT WERE ANALYZED AND NO FAILURE OR MALFUNCTION COULD BE FOUND. THE TESTED CLAMPS SHOWED NO VISUAL DEFECTS AND WORKED AS INTENDED. THE GAM CATH CATHETERS WITH ASSEMBLED CLAMP LOT ARE DISTRIBUTED WORLDWIDE. REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY FURTHER COMPLAINTS FROM OTHER CLINICS RELATED TO MALFUNCTION FROM THE ASSEMBLED CLAMP LOT. EVALUATION WAS DONE WITH RETAINED SAMPLE FROM IDENTICAL CLAMP LOT.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) HAD A GAM CATH 1320 J FEMORAL ACCESS CATHETER REPLACED PRIOR TO USING THE CATHETER AS THE ARTERIAL CLAMP WAS NOT CLAMPING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412566 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1320J (109511) 2014-11-2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other