BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMIX

    MDR report key: 12027225 · Received June 18, 2021

    Report

    Report Number
    1937141-2021-00013
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 18, 2021
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00812496011121
    PMA / PMN Number
    K030888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED UNIT WAS RETURNED DRAINED AND THE ISOLATED PARTICULATE WAS RECEIVED IN A SEPARATE BAG. THE PARTICULATE HAD A ROUND, FLAT SHAPE AND CONTAINED BOTH CLEAR AND BLACK AREAS. THE PARTICULATE WAS SENT TO AN EXTERNAL LAB FOR ANALYSIS AND THE RESULTS INDICATE IT IS COMPOSED OF POLYCARBONATE. THE INVESTIGATION INTO THIS EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE COMPOUNDING MILRINONE AND D5W INTO A CORMIX EMPTY EVA CONTAINER WITH 2 PORTS, THAT AN OBJECT WITH THE APPEARANCE OF LEGS AND A WING WERE VISIBLE INSIDE THE BAG. IT WAS FURTHER REPORTED THAT THE COMPOUNDING TECHNICIAN CUT THE BAG AND EXTRACTED IT FROM INSIDE USING A NEEDLE TO CONFIRM THAT IT WAS NOT CORING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926105 CORMIX 250 ML EMPTY EVA CONTAINER WITH 2 PORTS KPE THE METRIX COMPANY 64045 64045-A6330 00812496011121

    Patients

    Seq Age Sex Outcome Treatment
    1