BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER VIAL-MATE DAPTORS

    MDR report key: 2978554 · Received February 20, 2013

    Report

    Report Number
    MW5029096
    Event Type
    Other
    Date Received
    February 20, 2013
    Report Date
    December 6, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    LHI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER VIAL-MATE ADAPTORS ARE DESIGNED TO BE ATTACHED TO 20 MM CLOSURE DRUG VIALS AND BAXTER INTRAVENOUS SOLUTION BAGS FOR RECONSTITUTION JUST PRIOR TO MEDICATION ADMINISTRATION. USE OF VIAL-MATE ADAPTORS ALLOWS THE DISPERSING OF INTRAVENOUS DRUGS WHERE DRUG STABILITY IN SOLUTION IS LIMITED. THIS COMBINATION ALLOWS US TO STORE THE COMBINATION IN PYXIS MACHINES FOR THE NURSE TO USE WHEN AN ORDER IS RECEIVED. OUR HOSPITAL HAS BEEN USING BAXTER VIAL-MATE ADAPTORS WITH 100 ML 0.9% SODIUM CHLORIDE BAXTER BAGS (LIST 2B1302) AND ZOSYN 3.375 GRAM VIALS. WE NOTICED THAT WITH THIS COMBINATION OF DRUG AND BAG THAT THERE IS NOT ALWAYS ENOUGH AIR IN THE BAG TO DISPLACE THE DISSOLVED DRUG IN THE VIAL. WHEN THAT HAPPENS, NOT ALL OF THE ANTIBIOTIC IS TRANSFERRED INTO THE INFUSION BAG AND THE PATIENT RECEIVES A LESSER AMOUNT OF DRUG THAN WHAT WAS ORDERED. WE NOTICED THIS WITH ZOSYN 3.375 GRAM VIALS AND ALSO WITH THE GENERIC PIPERACILLIN AND TAZOBACTAM 3.375 GRAM VIALS. WE THINK THIS COULD HAPPEN WITH MANY OTHER DRUG COMBINATIONS AND MAY BE HAPPENING AT OTHER FACILITIES. UPON ACTIVATION, WHEN THE RECONSTITUTED VIAL HAS MORE VOLUME THAN THE VOLUME OF AIR IN THE INFUSION BAG THIS SITUATION CAN OCCUR AND RESULT IN THE PATIENT RECEIVING SUB-THERAPEUTIC DOSES. MEDICATION NOT ADMINISTERED TO OR USED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74650 BAXTER VIAL-MATE DAPTORS VIAL ADAPTORS LHI BAXTER HEALTHCARE CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 TAZOBACTAM 3.375 GRAM VIAL| ZOSYN 3.375 GRAM VIAL| GENERIC PIPERACILLIN 3.75 GRAM VIAL| BAXTER 100 MI 0.9% SODIUM BAG: LIST 2B1302