BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q2 MULTIPORT MANIFOLD IV ADMINSTRATION SET

    MDR report key: 3078043 · Received April 22, 2013

    Report

    Report Number
    1649914-2013-00019
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL'S AMBULATORY TREATMENT CENTER REPORTED AN ISSUE WITH AN INTRAVENOUS ADMINISTRATION SET INCLUDING THE MODEL 9527B MULTIPORT MANIFOLD. THE NURSING STAFF REPORTED THAT WHILE THE SET WAS DELIVERING CHEMOTHERAPY TO THE PT, THERE WAS A LEAK OBSERVED UNDER THE AIR FILTER OF THE MANIFOLD. THE REPORT NOTED THE LEAKAGE HAD COLLECTED ON THE PT'S BED AND ON THE FLOOR. IT WAS REPORTED THAT ABOUT 485CC OF THE 500CC OF BENDAMUSTINE (THE CHEMOTHERAPY AGENT) HAD BEEN DELIVERED TO THE PT WHEN THE LEAKAGE ISSUE WAS DISCOVERED. THE HOSPITAL REPORT STATED APPROX 20CC HAD LEAKED ONTO THE FLOOR AND AN UNK AMT ON THE PT'S BEDDING. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172000 Q2 MULTIPORT MANIFOLD IV ADMINSTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA QUEST MEDICAL, INC. 9527B 0428852S06

    Patients

    Seq Age Sex Outcome Treatment
    1