BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE®

    MDR report key: 8089126 · Received November 20, 2018

    Report

    Report Number
    9681240-2018-00026
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    B. BRAUN AVITUM ITALY S.P.A.
    Product Code
    KPE
    UDI-DI
    04046964200618
    PMA / PMN Number
    K041415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017. (B)(4). ONE (1) FILLED BAG WAS RECEIVED FOR EVALUATION. THE BAG AND THE SOLUTION WERE VISUALLY INSPECTED, AND NEITHER THE BAG NOR THE SOLUTION IN THE BAG SHOWED ANY BLUE DISCOLORATION. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. BASED ON THE RESULTS OF THIS INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2013017 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN ITALY S.P.A. (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: PHARMACIST WAS COMPOUNDING 8ML OF NITROPRUSSIDE (SAGENT MNFCTR) INTO 234ML OF DEXTROSE 5 PERCENT (BAXTER MNFCTR), THEN ADDED 8ML OF SODIUM THIOSULFATE (HOPE PHARMACEUTICALS). PREPARED THE INFUSION AND SENT TO THE NURSING UNIT IN AN AMBER BAG TO PROTECT FROM LIGHT UNTIL USE. WHEN THE NURSE REMOVED THE COMPOUNDED BAG FROM THE AMBER BAG, THE EVA BAG WAS BLUE. THE NITROPRUSSIDE AND SODIUM THIOSULFATE IN D5 WATER SOLUTION TURNED BLUE; NOT THE BAG ITSELF. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927795 PINNACLE® CONTAINER, I.V. KPE B. BRAUN AVITUM ITALY S.P.A. UNKNOWN 04046964200618

    Patients

    Seq Age Sex Outcome Treatment
    1