BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNON II PLUS REPLACEMENT HUB SET

    MDR report key: 6082174 · Received November 7, 2016

    Report

    Report Number
    1036844-2016-00559
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    NFK
    PMA / PMN Number
    K020430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR THE SECOND IN A SERIES OF TWO CONSECUTIVE PRODUCT PROBLEMS WITH THE SAME PATIENT. THE FIRST ISSUE HAS BEEN REPORTED UNDER MDR # 1036844-2016-00558.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND IT DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE PROBABLE CAUSE OF A LEAK IN THE CONNECTOR ASSEMBLY COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THIS IS THE SECOND COMPLAINT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT IN NEPHROLOGY, THE USER SUCCESSFULLY INSERTED A CHRONIC HEMODIALYSIS CATHETER INTO THE PATIENT'S JUGULAR. AFTER SIX MONTHS IN USE, THE NURSE FOUND LEAKAGE WHEN THE PATIENT HAD HEMODIALYSIS TREATMENT. AS A RESULT, NEW EXTENSION TUBE WAS REPLACED, HOWEVER, AFTER TWO HEMODIALYSIS TREATMENTS, THE EXTENSION TUBE CRACKED AGAIN. DOCTOR REPLACED ANOTHER NEW EXTENSION TUBE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO ADDITIONAL HARM TO THE PATIENT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. THE PATIENT INVOLVED WAS A (B)(6) YR/OLD MALE, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734320 CANNON II PLUS REPLACEMENT HUB SET CHRONIC HEMODIALYSIS PRODUCTS NFK ARROW INTERNATIONAL INC. 23F14F1348

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR