BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOSTREAM CHRONIC HEMODIALYSIS CATHETER

    MDR report key: 4878588 · Received June 26, 2015

    Report

    Report Number
    3003862657-2015-00003
    Event Type
    Other
    Date Received
    June 26, 2015
    Date of Event
    October 15, 2014
    Report Date
    May 1, 2015
    Manufacturer
    REX MEDICAL L.P.
    Product Code
    MSD
    PMA / PMN Number
    K071422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT F/U: REVIEW OF MEDWATCH REPORT; REVIEW OF TREND ANALYSIS. COMPLAINT SAMPLE EVALUATION: COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. RETAIN DEVICE EVALUATION: NO DEVICE RETAIN EVALUATION WAS PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE AS TO THIS PRODUCT COMPLAINT COULD NOT BE DETERMINED. THERE WAS NO INFO PROVIDED REGARDING THE CASE (I.E. PRODUCT CODE OR LOT NUMBER; PATIENT HEALTH HISTORY, ETC). ONE THING THAT WAS ABLE TO BE CONFIRMED VIA THE MEDWATCH REPORT WAS THAT THE PHYSICIAN PERFORMING THE PROCEDURE USED A DEVICE ON (B)(6) 2015 (EVENT DATE) YET THE HEMOSTREAM PRODUCT HAS NOT BEEN IN PRODUCTION SINCE 2010 MEANING THAT THE PHYSICIAN USED AN EXPIRED PRODUCT ON THEIR PATIENT (THE DEVICE HAD A SHELF LIFE OF THREE YEARS). FURTHER, IT APPEARS THAT THE DIRECTIONS FOR USE ON THE DEVICE WERE NOT FOLLOWED AS INDICATED AND THAT THE PROCEDURE WAS NOT PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED FOR THE AS THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE TREND ANALYSIS FOUND NO PREVIOUS INSTANCES OF A SIMILAR NATURE BEING REPORTED FOR THE HEMOSTREAM DIALYSIS CATHETER. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    AS REPORTED TO REX MEDICAL VIA ARGON PRODUCT EXPERIENCE REPORT FORM: I WANT TO POST A COMPLAINT ABOUT HEMOSTREAM DIALYSIS CATHETER MADE BY , BECAUSE IT HAS WRONG DESIGN THAT MAY PUT THE PATIENT'S LIFE AT RISK. THE CATHETER MENTIONED ABOVE HAS A TRIPLE ARTERIAL LUMEN OF WHICH ONE CLAMP IS CONTROLLING THE THREE LUMENS, WITH ONE OUTLET. IN CASE OF OCCLUSION (THROMBOSIS) OF ONE OR TWO OF THESE LUMENS AND DURING GIVING THE HEPARIN LOCK AT THE END OF DIALYSIS THE HEPARIN WILL FLOW ONLY THROUGH THE PATENT LUMEN WHICH AHS 1/3 OF THE SIZE WHILE WE GIVE AMOUNT ENOUGH TO FILL ALL THE LUMENS. SO THE HEPARIN LOCK WILL REACH THE BLOOD STREAM IN HIGH AMOUNT (1/3 OR 2/3 OF THE HEPARIN LOCK WILL REACH THE BLOOD STREAM DEPENDING ON HOW MANY LUMEN ARE THROMBOSED 1 OR 2). THIS IS BASED ON OUR EXPERIENCE WITH ONE HEMODIALYSIS PATIENT.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416026 HEMOSTREAM CHRONIC HEMODIALYSIS CATHETER HEMOSTREAM MSD REX MEDICAL L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other