BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM

    MDR report key: 15509056 · Received September 29, 2022

    Report

    Report Number
    9680794-2022-00608
    Event Type
    Death
    Date Received
    September 29, 2022
    Date of Event
    July 8, 2022
    Report Date
    September 5, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MSD
    UDI-DI
    30801902195556
    PMA / PMN Number
    K111117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S CAUSE OF DEATH WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S CAUSE OF DEATH WAS NOT PROVIDED. THE CUSTOMER RETURNED ONE, UNOPENED CHRONIC HEMODIALYSIS KIT FOR ANALYSIS. THIS CONTRADICTS THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED "DURING USE". THEREFORE, IT IS BEING ASSUMED THAT THE RETURNED SAMPLE IS A REPRESENTATIVE SAMPLE. THE REPRESENTATIVE KIT WAS OPENED, AND NO DEFECTS OR ANOMALIES WERE OBSERVED ON ANY OF THE COMPONENTS. THE CATHETER FROM THE REPRESENTATIVE KIT WAS TESTED USING A PRESSURIZED LEAK TESTER WITH THE COMPRESSION SLEEVE AND CAP FULLY THREADED ON THE CONNECTOR ASSEMBLY. THE RETURNED CATHETER BODY WAS CLAMPED AND THE LUMENS WERE CONNECTED TO A LAB LEAK TESTER. THE SAMPLE WAS TESTED PER BS EN ISO 10555-1, SECTION 4.7.1 (AMRQ-000162 REV. 04) WHICH STATES, "THERE SHALL BE NO LIQUID LEAKAGE IN THE FORM OF A FALLING DROP OF WATER AT 300-320 KPA (43.5-46.4 PSI) FOR 30 SEC WHEN TESTED PER BS EN ISO-10555-1 ANNEX C". THE LEAK TESTER WAS PRESSURIZED TO 300 KPA AND HELD FOR 30 SECONDS. NO LEAKS WERE OBSERVED. FROM THE REPRESENTATIVE SAMPLE, THE COMPRESSION CAP WAS INSERTED OVER THE COMPRESSION SLEEVE TOWARDS THE CONNECTION ASSEMBLY AND CONNECTED FIRMLY. A MANUAL TUG TEST ON THE CONNECTION WAS COMPLETED AND THE CONNECTION WAS SECURE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "GREEN COMPRESSION SLEEVE MUST BE PRESENT WHEN THREADING COMPRESSION CAP ONTO HUB CONNECTION ASSEMBLY. FAILURE TO DO SO MAY RESULT IN AIR EMBOLISM, BLOOD LOSS OR CATHETER SEPARATION". THE IFU ALSO STATES, "THREAD COMPRESSION CAP ONTO HUB CONNECTION ASSEMBLY FIRMLY, BUT DO NOT OVER TIGHTEN. THERE SHOULD BE NO THREADS VISIBLE ON HUB CONNECTION ASSEMBLY". THE CUSTOMER REPORT OF A LEAKING CATHETER WAS NOT ABLE TO BE CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER RETURNED A REPRESENTATIVE SAMPLE. NO DEFECTS OR ANOMALIES WERE OBSERVED ON THE REPRESENTATIVE CATHETER, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. LEAK TESTING WAS PERFORMED ON THE RETURNED REPRESENTATIVE CATHETER AND NO LEAKS WERE OBSERVED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, THE ROOT CAUSE CANNOT BE DETERMINED AS THE ACTUAL DEVICE WAS NOT RETURNED AND THE REPORTED ISSUE COULD NOT BE REPRODUCED WITH THE REPRESENTATIVE SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED, "DURING THE CONNECTION OF THE CATHETER TO DIALYSIS AN AIR LEAK WAS OBSERVED AT THE LEVEL OF THE CATHETER. THE DIALYSIS SESSION HAD TO BE STOPPED AND THE CATHETER REMOVED IN THE OPERATING ROOM." IT WAS REPORTED THE CATHETER WAS INSERTED ON (B)(6) 2022 AND WAS "WELL POSITIONED" AND "MONITORED BY X-RAY". THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. DIALYSIS WAS COMPLETED WITH THE NEW CATHETER. IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2022. "THE DECEASED OF THE PATIENT IS NOT LINKED TO THE CATHETER. THE INCIDENT DELAYED THE DIALYSE."

    Description of Event or Problem · 0

    IT WAS REPORTED, "DURING THE CONNECTION OF THE CATHETER TO DIALYSIS AN AIR LEAK WAS OBSERVED AT THE LEVEL OF THE CATHETER. THE DIALYSIS SESSION HAD TO BE STOPPED AND THE CATHETER REMOVED IN THE OPERATING ROOM." IT WAS REPORTED THE CATHETER WAS INSERTED ON (B)(6) 2022 AND WAS "WELL POSITIONED" AND "MONITORED BY X-RAY". THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. DIALYSIS WAS COMPLETED WITH THE NEW CATHETER. IT WAS REPORTED THE PATIENT DIED ON (B)(6) 2022. "THE DECEASED OF THE PATIENT IS NOT LINKED TO THE CATHETER. THE INCIDENT DELAYED THE DIALYSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634056 ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL LLC IPN920517 13F21J0846 30801902195556

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R HEMODIALYSIS.| HEMODIALYSIS.