BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO PRIMARIO PLUM CON CLAVE

    MDR report key: 3862917 · Received February 20, 2014

    Report

    Report Number
    9615050-2014-01365
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. TESTING AND INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT REC'D. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF REPOSITION SALINE, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. IT WAS REPORTED THAT IMMEDIATELY AFTER THE DELIVERY WAS STARTED, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106722 EQUIPO PRIMARIO PLUM CON CLAVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA 080355H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK