BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPIRA

    MDR report key: 6791391 · Received August 10, 2017

    Report

    Report Number
    MW5071539
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    July 18, 2017
    Report Date
    August 10, 2017
    Manufacturer
    HOSPIRA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING INFUSED WITH NIVOLUMAB (OPDIVO) UTILIZING THE HOSPIRA SAPPHIRE PUMPS. THIS DRUG AND THIS PUMP UTILIZE HOSPIRA PUMP TUBING WITH FILTER REF 12003-000-0027 HOSPIRA LOT NO. 16389-01. DRUG STARTED LEAKING AROUND FILTER AREA OF THE TUBING SET. DRUG STOPPED. INFUSION TERMINATED. NO ADVERSE EVENT AND NO SUBSEQUENT ISSUES WITH THIS PARTICULAR MODEL OF TUBING BUT JUST WANTED TO REPORT WHAT APPEARED TO BE FOR US AN ISOLATED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564304 HOSPIRA SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA AP231-01 690055G

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR