BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5194044 · Received November 1, 2015

    Report

    Report Number
    9616066-2015-01300
    Event Type
    Malfunction
    Date Received
    November 1, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK WAS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE PVC TUBING WAS COMPLETELY SEPARATED FROM THE MICRON FILTER OUTLET PORT. THE PVC TUBING WAS NOTICED TO BE SLIGHTLY EXPANDED AND BENT AS STATED BY THE CUSTOMER. VISUAL INSPECTION UNDER A MICROSCOPE FOUND AN INSUFFICIENT AMOUNT OF BONDING SOLVENT APPLIED AT THE INTERSECTION OF THE PVC TUBING AND THE FILTER PORT. NO CRACKS WERE OBSERVED ANYWHERE ON THE TUBING AND FILTER OUTLET PORT THOUGH. FUNCTIONAL AND DIMENSIONAL WAS NOT PERFORMED BECAUSE THE PVC TUBING WAS OVER-EXPANDED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE LEAK WAS FOUND TO BE A MANUFACTURING ISSUE DUE TO THE PVC TUBING BEING OVER-EXPANDED AND INSUFFICIENT SOLVENT BEING APPLIED AT THE JUNCTION OF THE PVC TUBING AND THE FILTER OUTLET PORT. THE INSUFFICIENT BONDING SOLVENT COMBINED WITH THE OVER-EXPANDED TUBING CAUSED THE FILTER TO DETACH FROM THE TUBING, THUS CREATING A LEAK.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKAGE FROM THE PROXIMAL CONNECTION SITE WHILE INFUSING ERBITUX IN THE ONCOLOGY INFUSION CENTER. THE LEAK WAS NOTICED AS THE INFUSION WAS COMPLETE AND THE NURSE WAS DISCONNECTING THE TUBING FROM THE PATIENT. THE TUBING ALSO APPEARED TO HAVE A BEND IN IT, AS WELL AS A "POSSIBLE CRACK". THERE WAS NO PATIENT HARM AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724400 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010454 15066603

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR