BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALINDROME

    MDR report key: 7621385 · Received June 20, 2018

    Report

    Report Number
    3009211636-2018-00208
    Event Type
    Injury
    Date Received
    June 20, 2018
    Report Date
    June 20, 2018
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    MSD
    UDI-DI
    20884521158495
    PMA / PMN Number
    K123196
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CATHETER'S VENOUS LUER ADAPTER WAS DETACHED OR DISCONNECTED FROM THE FEATURE MANIPULATION ENGINE(FME) GENERATOR. THE PATIENT LOST 250ML OF BLOOD AND 2 POINTS OF HEMOGLOBIN BASED ON THE BLOOD NUMBERING REQUIRED BY THE PHYSICIAN. THE PATIENT WAS PLUGGED AGAIN AND FINISHED THE DIALYSIS SESSION. IT WAS STATED THAT WHEN THE CATHETER WAS USED ON FME GENERATORS, THE LUER LOCK COULD NOT BE SCREWED COMPLETELY AND THERE WAS AT LEAST ONE TURN OF THE SCREW MISSING WHICH INCREASES THE DISCONNECTION RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463466 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN MFG SOLUTIONS S.A. 8888541019P 1720700126 20884521158495

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R FEATURE MANIPULATION ENGINE(FME) GENERATOR