BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 11982825 · Received June 11, 2021

    Report

    Report Number
    1937141-2021-00010
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 11, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00085412477473
    PMA / PMN Number
    K960581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S MOTHER CALLED THE HOSPITAL TO REPORT THAT PARENTERAL NUTRITION SOLUTION WAS LEAKING BETWEEN THE CHAMBERS OF AN EXACTAMIX 3000 ML DUAL CHAMBER EVA BAG. THIS WAS IDENTIFIED AT THE PATIENT'S HOME PRIOR TO USE. IT WAS FURTHER REPORTED THAT THE PATIENT NOTICED THE LEAK BEFORE ACTIVATING THE DUAL CHAMBER BAG AND THAT THE LIPID FROM THE TOP CHAMBER WAS LEAKING INTO THE BOTTOM CHAMBER. IT IS UNCLEAR IF THE BAG WAS PARTIALLY ACTIVATED ALREADY, OR IF THERE WAS AN ISSUE WITH THE SEAL BETWEEN THE TWO CHAMBERS. AS THE LEAK WAS BETWEEN THE CHAMBERS, NO PARENTERAL NUTRITION SOLUTION SPILLED FROM THE BAG TO THE OUTSIDE ENVIRONMENT. THERE WAS NO MENTION OF THE CONDITION OF THE DIVIDING ROD OR WHETHER IT WAS PLACED CORRECTLY. AFTER NOTICING THE LEAK, THE PATIENT ACTIVATED THE BAG AND THEN DISCARDED IT. NO PHOTOGRAPHS HAVE BEEN PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884908 EXACTAMIX 3000 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938905 63630-A5971 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1