BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX

    MDR report key: 11901877 · Received May 28, 2021

    Report

    Report Number
    1937141-2021-00008
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    December 17, 2020
    Report Date
    May 28, 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

    NO SAMPLE WAS AVAILABLE FOR EVALUATION BUT PHOTOGRAPHS WERE PROVIDED. NO ABNORMALITIES OR ISSUES WERE NOTED WITH THE EXACTAMIX 3000ML DUAL CHAMBER BAG FROM THE PHOTOGRAPHS PROVIDED. THE ADMINISTRATION SET, WHICH IS NOT A COMPONENT OF THE BAG, WAS VISIBLY KINKED PER THE PHOTOGRAPHS PROVIDED. ISSUES WERE REPORTED WITH THE ADMINISTRATION SET AND THE PUMP. THERE IS CURRENTLY NO INFORMATION AVAILABLE TO INDICATE THAT THE BAG MALFUNCTIONED. THIS SUBMISSION IS BEING MADE OUT OF AN ABUNDANCE OF CAUTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE UNIT OF BODYGUARD 323 COLOUR VISION PD WAS OBSERVED TO HAVE UNDERINFUSED TPN CONTAINED WITHIN AN EXACTAMIX 3000ML DUAL CHAMBER EVA BAG. IT WAS FURTHER REPORTED THAT THE PATIENT PUMP WAS PROGRAMMED TO DELIVER 2345 ML OVER 14 HOURS WITH 1 HOUR UP TIME AND 1 HOUR DOWN TIME. THE TOTAL BAG VOLUME WAS STATED AS 2530 ML. AT THE END OF INFUSION PATIENT TPN BAG HAD AN OBSERVED OVERAGE APPROXIMATELY 800 ML AS OPPOSED TO THE EXPECTED 200 ML. IT WAS REPORTED THAT THE PATIENT'S FATHER MENTIONED THAT THE PUMP DID ALARM WITH UP/AIR OCCLUSION AT APPROXIMATELY 12 AM WHEN THEY REMOVED THE LINE TO RECTIFY THE AIR IN LINE ALARM, THEY NOTICED THAT THE LINE HAD A KINK WHERE THE PUMPING MECHANISM SEGMENT WAS LOCATED. WHEN THE LINE WAS REINSERTED THE PUMP CONTINUED TO FUNCTION WITH ONLY ONE SUBSEQUENT ALARM AT 2:45 AM. THIS ALARM WAS ALSO RECTIFIED AND THE PUMP CONTINUED UNINTERRUPTED UNTIL THE END OF INFUSION. IT WAS REPORTED THAT A PUMP SWAP OUT WAS REQUIRED. THERE WAS PATIENT INVOLVEMENT AS THIS WAS NOTICED DURING PATIENT INFUSION BUT THERE WAS NO HARM NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801636 EXACTAMIX 3000 ML EMPTY EVA DUAL CHAMBER BAG KPE THE METRIX COMPANY H938905 63630-A5953 00085412477473

    Patients

    Seq Age Sex Outcome Treatment
    1