BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMCATH

    MDR report key: 5170422 · Received October 23, 2015

    Report

    Report Number
    3004367028-2015-00004
    Event Type
    Injury
    Date Received
    October 23, 2015
    Date of Event
    September 25, 2015
    Report Date
    December 16, 2015
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K100451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE VISUAL INVESTIGATION OF THE COMPLAINED SAMPLE CONFIRMED A KINK OF THE ARTERIAL EXTENSION LINE. INVESTIGATION OF RETAIN SAMPLE FROM EXTENSION LINE MATERIAL THE RETAIN SAMPLES FROM THE EXTENSION LINE TUBING (EXTERNAL LOTS FROM 01. JANUARY 2013- 30.OCTOBER 2015) WERE TESTED. ALL TESTED SAMPLES SHOW NO KINKING OR BENDING EFFECT. NO DEVIATION COULD BE EVALUATED WITHIN THE TEST. DOCUMENT AND DATA INVESTIGATION: GAMCATH GDHK-1125 LOT NUMBER OF THE CATHETER IS UNKNOWN. BASED ON REPORTED INFORMATION FROM ICU POSSIBLE LOTS COULD BE: 2015-02-1089; LOT SIZE: 150 , 2014-09-1823; LOT SIZE: 150, 2014-04-1384; LOT SIZE: 100, 2014-01-1010; LOT SIZE: 100. THE DHR RECORDS FROM THE MENTIONED POSSIBLE PRODUCT LOTS SHOW NO IRREGULARITY FOR THE MANUFACTURING PROCESS AND PERFORMED PRODUCT TESTS DURING MANUFACTURING. THE LOT HISTORY RECORD CHECKS DO NOT GIVE ANY INFORMATION THAT REASONABLY SUGGESTS A GENERAL LOT PROBLEM. THE COMPLAINT DATA CHECK FOR THE INVOLVED GAMCATH GDHK-1125 TYPE (COMPLAINT DATA BASE: TW DATA FOR THE YEAR 01.JANUARY 2013 UP TO 13. NOVEMBER, 2015) DO NOT SHOW ANY FURTHER COMPARABLE COMPLAINT WITH ASSOCIATED PROBLEM "CATHETER WAS KINKED AT THE LEVEL OF THE RED ARTERIAL CLAMP". CONCLUSION: IN CONCLUSION, THE ROOT CAUSE IS NOT ATTRIBUTED FROM PRODUCT NON-CONFORMITY. THE CATHETER IS DELIVERED WITH OPEN CLAMPS IN THE PACKAGE FROM THE MANUFACTURER AND WAS ACCORDING TO THE CUSTOMER FLUSHED WITH SALINE AT TIME OF INSERTION WITHOUT ANY ISSUES OBSERVED. FURTHER INFORMATION ABOUT USED CATHETER BANDAGE / FIXATION WAS REQUESTED BUT NOT PROVIDED. BASED ON RECEIVED INFORMATION, IT CANNOT BE RULED OUT THAT THE CATHETER MIGHT HAVE BEEN LOCATED IN A POSITION RESULTING IN THE REPORTED KINK. THE KINKING MIGHT BE LINKED TO MECHANICAL FORCE EFFECT WHICH HAD CAUSED A KINKING OF THE EXTENSION LINE TUBING. ONE ROOT CAUSE MIGHT BE A NOT SUFFICIENT BANDAGE OR FIXATION OF THE CATHETER AND/OR BLOOD LINES DURING OR BETWEEN TREATMENTS. INSUFFICIENT FIXATION MAY LEAD TO A TENSILE FORCE WHICH MAY LEAD TO THE COMPLAINED KINKING EFFECT OF THE EXTENSION LINE TUBING. THIS IS ALSO WRITTEN WITHIN THE MANUAL UNDER THE CHAPTER ¿TROUBLES SHOOTING UNDER CHAPTER KINKING". FINAL TECHNICAL ASSESSMENT: THE BATCH REVIEW OF THE POSSIBLE CATHETER LOTS AND THE ANALYSIS OF THE RETAIN SAMPLES DIDN¿T CONFIRM THE REPORTED ISSUE. HOWEVER, THE ACTUAL SAMPLE ANALYSIS IDENTIFIED A KINK OF THE ARTERIAL EXTENSION LINE. BASED ON LIMITED INFORMATION, A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED BUT MIGHT BE RELATED TO A FIXATION / BANDAGE PROBLEM.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) HAD A GAMCATH GDHK-1125 VASCULAR ACCESS CATHETER INSERTED. AT THE TIME OF INSERTION THERE WERE NO VISIBLE DEFECTS OF THE CATHETER AND FOLLOWING INSERTION THE CATHETER WAS FLUSHED WITH SALINE PER THE UNIT'S PROTOCOL. DURING THE INITIAL USE OF THE CATHETER A KINK WAS OBSERVED AT THE LEVEL OF THE RED ARTERIAL CLAMP WHICH PREVENTED BLOOD FROM PASSING THROUGH. THE CATHETER WAS REMOVED AND A NEW VASCULAR ACCESS CATHETER WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701902 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH GDHK-1125 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention