BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXA EXACTAMIX 2400 COMPOUNDER VALVE SET

    MDR report key: 14695221 · Received June 14, 2022

    Report

    Report Number
    MW5110310
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    April 19, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BAXA / BAXTER HEALTHCARE CORPORATION
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHARMACIST NOTICED COMPOUNDED DEXTROSE 50% AND SOME TPNS THAT SHOULD BE CLEAR WERE SLIGHTLY CLOUDY. TPNS WERE DECIDED TO BE APPROPRIATE FOR USE AFTER REVIEW WITH THE DIRECTOR. THE DEXTROSE BAGS WERE RERUN AFTER MULTIPLE ATTEMPTS OF FLUSHING AND RE-PRIMING PORTS ON COMPOUNDER. INVESTIGATION THE FOLLOWING DAY FOUND THAT REPORTS TO FDA EXISTED WITH CONSUMERS/INSTITUTIONS HAVING SAME ISSUES WITH BAXA EXACTAMIX 2400 COMPOUNDER VALVE SETS HAVING LEAKAGE AND TRACE AMOUNTS OF LIPIDS LEAKING INTO NON-LIPID CONTAINING TPNS. LOT NUMBERS WERE LISTED AND REVIEWED AND MOST REPORTS WERE SINCE MID MARCH 2022 BUT OUR CURRENT LOT NUMBER WAS NOT LISTED. LINK TO WEBSITE (HTTPS://MAUDE.INNOLITICS.COM/PRODUCTCODES/NEP?KEYWORD=BAXTER%20EM2400 ) WHERE REPORTS WERE LISTED WAS EMAILED TO DIRECTOR OF PHARMACY. BAXA WAS CALLED AND THEY DID NOT LIST THIS AS A PROBLEM BUT STATED THAT OUR VALVE ON OUR COMPOUNDER MAYBE GOING BAD. THEY ADVISED US TO MOVE OUR LIPIDS TO A DIFFERENT PORT WHICH WE DID. THIS LEAD TO MULTIPLE FAILURES/ISSUES ON OUR COMPOUNDER LEADING TO THE SWAP OF THE PUMP PORTION OF THE COMPOUNDER WITH THE BACKUP PUMP. TPNS AND DEXTROSE ON (B)(6) 2022 WERE CRYSTAL CLEAR HAVING BEEN RUN ON NEW COMPOUNDER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659048 BAXA EXACTAMIX 2400 COMPOUNDER VALVE SET SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXA / BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 01 DA Unknown Other