BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMCATH

    MDR report key: 4009981 · Received August 14, 2014

    Report

    Report Number
    3004367028-2014-00003
    Event Type
    Death
    Date Received
    August 14, 2014
    Date of Event
    April 30, 2014
    Report Date
    August 14, 2014
    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

    BASED ON LIMITED INFORMATION AND THE FACT THAT THE SAMPLE WAS NOT AVAILABLE A TECHNICAL INVESTIGATION COULD NOT BE PERFORMED. THE LOT NUMBER OF INVOLVED CATHETER GAMCATH GDHK-1315 IS UNKNOWN THEREFORE, A CHECK OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE. WITHIN THE COMPLAINT HISTORY CHECK FOR THE PRODUCT GROUP GAMCATH GDHK-13 FRENCH SIZE, NO SIMILAR COMPLAINT IS KNOWN.

    Description of Event or Problem · 1

    GAMBRO RECEIVED LIMITED CLINICAL INFORMATION RELATED TO THIS EVENT THAT OCCURRED IN THE (B)(6). THE HOSPITAL HAS DECLINED TO PROVIDE FURTHER INFORMATION RELATED TO THIS EVENT. IT WAS REPORTED THAT A PATIENT IN THE ICU HAD A GAM CATH GDHK 1315 INSERTED. PLACEMENT OF THE CATHETER WAS CONFIRMED VIA X-RAY AND CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) WAS INITIATED. APPROXIMATELY AN HOUR LATER, THE PATIENT HAD A TRANSIENT ISCHEMIA ATTACK WHICH RESOLVED SOMETIME LATER. THREE DAYS AFTER , THE PATIENT SUFFERED A RIGHT ANTERIOR CEREBRAL ARTERY TERRITORY INFARCT. FOLLOWING THIS EVENT, IT WAS DETERMINED THE CATHETER WAS IN AN ARTERY AND THE CATHETER WAS REMOVED. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL AND LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485694 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1315 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death