BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEHP FREE LS LF PLUMSET-OL CP D-CHAN

    MDR report key: 3833061 · Received March 25, 2014

    Report

    Report Number
    9615050-2014-02253
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 24, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THAT SOLUTION LEAKED FROM A SMALL STRAIGHT CUT IN THE TUBING 2.5 INCHES PROXIMAL TO THE CASSETTE. THE PROBABLE CAUSE OF THE CUT IN THE TUBING COULD HAVE BEEN DUE TO THE TUBING CUTTER MACHINE DURING MFG. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION BETWEEN THE CASSETTE AND DISTAL END OF THE TUBING SET ONTO THE FLOOR. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173833 DEHP FREE LS LF PLUMSET-OL CP D-CHAN 80FPA FPA HOSPIRA COSTA RICA LTD. NA 340425H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA