BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMCATH

    MDR report key: 3501967 · Received December 5, 2013

    Report

    Report Number
    3004367028-2013-00005
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 13, 2013
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K040301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GAM CATH INVOLVED IN THIS EVENT WAS ANALYZED AND NO FAILURE OR MALFUNCTION COULD BE FOUND. BOTH THE ARTERIAL AND VENOUS SHOWED NO VISUAL DEFECTS AND WORKED AS INTENDED. THE GAM CATH CATHETERS ARE DISTRIBUTED WORLDWIDE. REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY COMPLAINTS RELATED TO THE CLAMPS AUTOMATICALLY OPENING. GAMBRO RECEIVED NO INFORMATION TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT WHO WAS TREATED WITH PERITONEAL DIALYSIS WAS ADMITTED TO THE HOSPITAL WITH SEPSIS SECONDARY TO PERITONEAL PSEUDOMONAS. ON (B)(6) 2013, A GAM CATH 1315 CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR FOR ACCESS TO CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). CRRT WAS INITIATED ON A PRISMAFLEX MACHINE WITH A PRISMAFLEX ST FILTER SET. FOUR DAYS LATER, THE PATIENT EXPERIENCED AN AIR EMBOLISM. AT THE TIME OF THIS EVENT, THE PATIENT WAS DISCONNECTED FROM THE PRISMAFLEX MACHINE AND FILTER SET. ACCORDING TO THE MEDICAL STAFF; WHILE THE NURSE WAS FLUSHING THE CATHETER, THE ARTERIAL CLAMP OF THE CATHETER REOPENED AND AIR ENTERED THE PATIENT. THE PATIENTS¿ OXYGEN SATURATION DECREASED TO 65% AND THE PATIENT BEGAN COUGHING. OXYGEN WAS ADMINISTERED AND THE PATIENT WAS TREATED IN THE HYPERBARIC OXYGEN CHAMBER FOR SEVEN HOURS. THE PATIENT HAD NO ADDITIONAL SYMPTOMS AND WAS TRANSFERRED BACK TO THE ¿ACUTE¿ DEPARTMENT LATER IN THE DAY. CRRT WAS INITIATED THE FOLLOWING DAY UTILIZING THE SAME CATHETER WITHOUT ANY ISSUES. THE CATHETER WAS REPLACED A DAY LATER AND RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO ISSUES FOUND WITH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631067 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1315 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention