BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMCATH

    MDR report key: 3406550 · Received October 11, 2013

    Report

    Report Number
    3004367028-2013-00003
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    September 7, 2013
    Report Date
    September 12, 2013
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K040301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT EXPERIENCED A 200 - 300 ML BLOOD LOSS FROM A CRACKED VENOUS FEMALE LUER LOCK CONNECTOR ON THE GAMCATH GDHK-1315. TREATMENT WAS TERMINATED AND THE GAM CATH REMOVED AND DISCARDED. THE PHOTOS PROVIDED OF THE CATHETER CONFIRM THE PRESENCE OF A CRACK IN THE VENOUS FEMALE LUER LOCK. CONNECTOR. THE PHOTOS ALSO SHOW THE PRESENCE OF MARKS ON THE SURFACE OF THE GRIPS INDICATING THAT A CLAMP OR OTHER MECHANICAL FORCE HAS BEEN USED WHEN CONNECTING/DISCONNECTING THE CATHETER. THE DEVICE HISTORY RECORD FOR THE USED GAMCATH GDHK-1315 WITH LOT NUMBER 2013-06-1566 SHOW THAT THE CATHETER WAS PRODUCED AND TESTED WITHOUT ANY NONCONFORMITY AND NO SIMILAR COMPLAINT WAS REPORTED. THE ROOT CAUSE OF THE CRACK IS NOT KNOWN BUT MOST LIKELY THE RESULT OF USE ERROR FROM MECHANICAL FORCE CONNECTING OR DISCONNECTING THE LUER.

    Description of Event or Problem · 1

    AN ELDERLY PATIENT IN THE (B)(6) WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY WHEN THE NURSE OBSERVED BLOOD LEAKING FROM THE VENOUS SIDE OF THE VASCULAR ACCESS CATHETER. TREATMENT WAS STOPPED AND THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT RESULTING IN AN APPROXIMATE BLOOD LOSS OF 200 ¿ 300 ML. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE BLOOD LOSS AND REQUIRED NO MEDICAL INTERVENTION. TREATMENT WAS TERMINATED AND THE VASCULAR ACCESS CATHETER WAS REMOVED. FOLLOWING THE REMOVAL OF THE CATHETER, THE MEDICAL STAFF OBSERVED A CRACK ON THE VENOUS FEMALE LUER LOCK CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522154 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1315 2013-06-1566

    Patients

    Seq Age Sex Outcome Treatment
    1 Other