BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM

    MDR report key: 7147863 · Received December 27, 2017

    Report

    Report Number
    3006425876-2017-00597
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE LOT NUMBER WAS NOT REPORTED; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THE SALES HISTORY OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: " ON (B)(6), DURING A DECARBOXYLATION TREATMENT USING A KIT HP-X, A PRISMALUNG KIT AND A PRISMAFLEX MONITOR, AN AIR ENTRANCE IN THE ACCESS LINE OCCURRED. THE ACCESS AND RETURN LINES OF THE KIT HP-X WERE CONNECTED TO A CATHETER ARROW 14F/20 CM OF LENGTH, PLACED IN RIGHT FEMORAL POSITION. THE MEDICAL STAFF WAS INFORMED OF THE AIR ENTRANCE, FOLLOWING THE TRIGGERING OF ALARMS THE PRISMAFLEX MONITOR. AT THIS TIME, THE NURSE IN CHARGE OF THIS TREATMENT NOTICED THAT THE ACCESS LINE WAS FULL OF AIR, ALL ALONG THE LINE. SO, THE NURSE DISCONNECTED THE PATIENT AND THEN SHE CHECKED THE CATHETER: IT WAS NOT ABLE TO DELIVER A BLOOD FLOW RATE. CLINICAL CONSEQUENCES: THE PATIENT, A FEMALE OF (B)(6) HAD AN ACUTE RESPIRATORY DISTRESS SYNDROME. ACCORDING TO A PHYSICIAN OF THIS MEDICAL REANIMATION, THIS PATIENT WAS POSSIBLY IN HYPOVOLEMIA. SO, HIS HYPOTHESIS IS THAT THE CATHETER WAS "STICK" TO THE WALL OF THE BLOOD ACCESS, WHICH INDUCED THE EXTREMELY NEGATIVE BLOOD ACCESS PRESSURE AND THE AIR ENTRANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: " ON (B)(6), DURING A DECARBOXYLATION TREATMENT USING A KIT HP-X, A PRISMALUNG KIT AND A PRISMAFLEX MONITOR, AN AIR ENTRANCE IN THE ACCESS LINE OCCURRED. THE ACCESS AND RETURN LINES OF THE KIT HP-X WERE CONNECTED TO A CATHETER ARROW 14F / 20 CM OF LENGTH, PLACED IN RIGHT FEMORAL POSITION. THE MEDICAL STAFF WAS INFORMED OF THE AIR ENTRANCE, FOLLOWING THE TRIGGERING OF ALARMS THE PRISMAFLEX MONITOR. AT THIS TIME, THE NURSE IN CHARGE OF THIS TREATMENT NOTICED THAT THE ACCESS LINE WAS FULL OF AIR, ALL ALONG THE LINE. SO, THE NURSE DISCONNECTED THE PATIENT AND THEN SHE CHECKED THE CATHETER: IT WAS NOT ABLE TO DELIVER A BLOOD FLOW RATE. CLINICAL CONSEQUENCES: THE PATIENT, A FEMALE OF (B)(6), HAD AN ACUTE RESPIRATORY DISTRESS SYNDROME. ACCORDING TO A PHYSICIAN OF THIS MEDICAL REANIMATION, THIS PATIENT WAS POSSIBLY IN HYPOVOLEMIA. SO, HIS HYPOTHESIS IS THAT THE CATHETER WAS "STICK" TO THE WALL OF THE BLOOD ACCESS, WHICH INDUCED THE EXTREMELY NEGATIVE BLOOD ACCESS PRESSURE AND THE AIR ENTRANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926456 ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR