BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB

    MDR report key: 20277530 · Received September 23, 2024

    Report

    Report Number
    9680794-2024-00941
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 28, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MPB
    PMA / PMN Number
    K993933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, TWO-LUMEN MULTI-LUMEN ACCESS CATHETER (MAC), A CATH-GARD, AND AN 8FR SWAN-GANZ CATHETER FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE RETURNED COMPONENTS. REVIEW OF THE BILL OF MATERIALS (BOM) REVEALED THAT FINISHED GOOD CDC-22142-1A DOES NOT INCLUDE A MAC NOR A CATH-GARD IN THE KIT COMPONENTS. THIS SUGGESTS THE CUSTOMER EITHER RETURNED THE INCORRECT DEVICES OR REPORTED THE INCORRECT MATERIAL NUMBER. SIMULATED USE OF THE MAC WAS PERFORMED PER A KIT WITH A MAC PRODUCT INSTRUCTIONS-FOR-USE (IFU). A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO BOTH EXTENSION LINES AND FLUSHED. NO LEAKS OR BLOCKAGES WERE OBSERVED WHEN FLUSHING EITHER LUMEN. BOTH LUMENS FLUSHED AS INTENDED. THE HEMOSTASIS VALVE AND MAC DEVICE WERE LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER AMRQ-000038 REV.13: 1.) LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.6): THIS STATES, "IF THE SHEATH INTRODUCER HAS AN INTEGRAL HEMOSTASIS VALVE, WHEN TESTED AS DESCRIBED IN ANNEX E OF BS EN ISO 11070, USING A TEST PRESSURE OF 38-42 KPA MAINTAINED FOR 30S, THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM ONE OR MORE FALLING DROPS OF WATER." THE MAC WAS ATTACHED TO A LAB LEAK TESTER. WITH THE DISTAL END OF THE MAC OCCLUDED, EACH EXTENSION LINE ON THE SHEATH WAS INDIVIDUALLY PRESSURIZED TO 42 KPA FOR 30 SECONDS. NO LEAKS WERE OBSERVED, WHICH INDICATES THAT THE SHEATH VALVES ARE FUNCTIONING AS INTENDED. 2.) LIQUID LEAKAGE - HEMOSTASIS VALVE WITH CATHETER ADVANCED (AMRQ-000038 SECTION 7.2.7): THE PARAMETERS FROM THE LOW-PRESSURE LEAK RESISTANCE TEST WERE REPEATED THE RETURNED 8 FR SWAN-GANZ CATHETER INSERTED PAST THE SHEATH VALVES AND THE DISTAL END OF THE MAC OCCLUDED. EACH EXTENSION LINE ON THE SHEATH WAS INDIVIDUALLY PRESSURIZED TO 42 KPA FOR 30 SECONDS AND NO LEAKS WERE OBSERVED AT THE VALVES. THE TEST WAS REPEATED WITH A LAB INVENTORY 7 FR SWAN-GANZ CATHETER, AND NO LEAKS WERE OBSERVED AT THE VALVES NOR ANYWHERE ON THE DEVICE. NOTE: A MAC IS INTENDED FOR USE WITH 7-8 FR CATHETERS, BUT 7 FR CATHETER SIZE REPRESENTS A WORST-CASE SCENARIO FROM LIQUID LEAKAGE THROUGH HEMOSTASIS VALVE VIEWPOINT - CATHETERS WITH LARGER OUTER DIAMETER (7.5 OR 8 FR) BETTER OCCLUDE THE SEAL IN THE HEMOSTASIS VALVE. 3.) HIGH PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.5): THIS STATES, "WHEN TESTED AS DESCRIBED IN ANNEX D OF BS EN ISO 11070, USING A TEST PRESSURE OF 300-320 KPA MAINTAINED FOR 30S, THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM ONE OR MORE FALLING DROPS OF WATER." THE SHEATH WAS ATTACHED TO A LAB LEAK TESTER. WITH BOTH THE DISTAL END OF THE MAC AND THE HEMOSTASIS VALVE OCCLUDED, EACH EXTENSION LINE WAS PRESSURIZED TO 300 KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE MAC, WHICH INDICATES THAT THE SHEATH ASSEMBLY IS INTACT, AND THE SHEATH VALVES ARE FUNCTIONING AS INTENDED. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER TAKEN FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF INSERTION SITE LEAK WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE MAC AND A CATH-GARD. REVIEW OF THE BOM FOR REPORTED FINISHED GOOD CDC-22142-1A DOES NOT INCLUDE A MAC NOR A CATH-GARD IN THE KIT COMPONENTS. THIS SUGGESTS THE CUSTOMER EITHER RETURNED THE INCORRECT DEVICES OR REPORTED THE INCORRECT MATERIAL NUMBER. DESPITE THIS, THE RETURNED MAC PASSED FUNCTIONAL LEAK TESTING PERFORMED PER BS EN ISO 11070 AND NO EVIDENCE OF LEAKAGE, BACKFLOW, OR INTERLUMEN CROSSOVER WAS OBSERVED WITH ANY OF THE LUMENS OR THE SHEATH VALVES WHEN TESTED WITH 7FR AND 8FR COMPANION CATHETERS. A DEVICE HISTORY RECORD REVIEW ON A POTENTIAL LOT FROM SALES HISTORY DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THESE CIRCUMSTANCES AND THE CUSTOMER DESCRIPTION, THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE DISCREPANCY BETWEEN THE REPORTED DEVICE AND THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLETE UDI NOT AVAILABLE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "CATHETER IS LEAKING AT INSERTION SITE. I WAS TOLD THAT THIS ISSUE HAS OCCURRED BEFORE IN THE PAST 2 MONTHS SO IT DOES NOT SOUND LOT SPECIFIC. THE LINE WAS UNUSABLE FOR THE ADMINISTRATION OF FLUIDS, MEDICATIONS, AND BLOOD PRODUCTS DUE TO LEAKAGE OF BOTH LUMENS, AND SO THE PATIENT REQUIRED AN ADDITIONAL INVASIVE PROCEDURE TO OBTAIN ADEQUATE VASCULAR ACCESS." ASSOCIATED COMPLAINTS: 9680794-2024-00940.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "CATHETER IS LEAKING AT INSERTION SITE. I WAS TOLD THAT THIS ISSUE HAS OCCURRED BEFORE IN THE PAST 2 MONTHS SO IT DOES NOT SOUND LOT SPECIFIC. THE LINE WAS UNUSABLE FOR THE ADMINISTRATION OF FLUIDS, MEDICATIONS, AND BLOOD PRODUCTS DUE TO LEAKAGE OF BOTH LUMENS, AND SO THE PATIENT REQUIRED AN ADDITIONAL INVASIVE PROCEDURE TO OBTAIN ADEQUATE VASCULAR ACCESS." ASSOCIATED COMPLAINTS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590936 ARROW HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB CATHETER HEMODIALYSIS IMPLANTE MPB ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.| NOT REPORTED.