BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 6625553 · Received June 8, 2017

    Report

    Report Number
    9616066-2017-00827
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 11, 2017
    Report Date
    May 11, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 250ML BAXTER BAG NDC 0338-0049-02, LOT NUMBER Y231696, EXP OCT 18, CARBOPLATIN AND 0.9% NACL; 250ML BAXTER BAG NDC 0338-0049-02, LOT NUMBER Y229328, EXP SEP 18, 0.9% NACL, THERAPY DATE (B)(6)2017. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK OCCURRED AT THE TEXIUM ON THE SECONDARY SET WHERE IT CONNECTED TO THE SMART SITE OF THE PRIMARY SET WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. NO OTHER ANOMALIES OR EVIDENCE OF DAMAGE WERE OBSERVED ON THE SETS. FUNCTIONAL AND PRESSURE TESTING RESULTED IN THE SETS FLOWING FREELY AND RAN WITH NO LEAKING AT THE TEXIUM. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE SUSPECT SET WAS NOT RECEIVED AND THE INVESTIGATION WAS PERFORMED ONLY ON CONCOMITANT AND UNUSED ASSOCIATED SETS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A SECONDARY INFUSION OF PERTUZUMAB, A LEAK OCCURRED AT THE TEXIUM ON THE SECONDARY SET WHERE IT CONNECTED TO THE SMART SITE OF THE PRIMARY SET. THERE IS NO PATIENT HARM..

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SECONDARY PERTUZUMAB INFUSION, A LEAK OCCURRED ON THE SECONDARY TUBING WHERE THE TEXIUM WAS CONNECTED TO THE PROXIMAL SMARTSITE OF THE PRIMARY SET. THE LEAK DID NOT TOUCH THE PATIENT, HOWEVER IT WAS REPORTED THAT STAFF MEMBERS WERE EXPOSED TO THE CHEMOTHERAPY, AND THAT A SPILL KIT WAS USED TO CONTAIN THE SPILL. IT WAS ALSO REPORTED THAT THE SPILL DID LEAD TO A DELAY IN RECEIVING THE CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402612 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 70001B-07T 16096748

    Patients

    Seq Age Sex Outcome Treatment
    1