BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    MDR report key: 3833083 · Received March 25, 2014

    Report

    Report Number
    9615050-2014-02261
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 13, 2014
    Report Date
    March 3, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS REC'D AND EVALUATED. TESTING FOUND THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET WAS PARTIALLY TORN OFF. WHITE DRAG MARKS WERE NOTED INDICATING THE USE OF FORCE. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF DEVICE BREAKAGE OF THE CLAVE SECONDARY PORT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE DEVICE BREAKAGE WAS DUE TO THE DESIGN OF CLAVE PORT THAT IS DIRECTLY BONDED TO THE SECONDARY PORT OF THE CASSETTE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CRACK IN THE SEMI-RIGID ADAPTER OF THE CLAVE SECONDARY PORT. IT WAS REPORTED THAT THE TUBING SET HAD BEEN USED TO DELIVER EITHER AN UNSPECIFIED CONCENTRATION OF SALINE OR 5% DEXTROSE IN WATER, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. IT WAS REPORTED THAT AFTER THE PATIENT WAS DISCONNECTED FROM THE TUBING SET, IT WAS NOTED THAT THE SEMI-RIGID ADAPTER OF THE CLAVE SECONDARY PORT ON THE CASSETTE OF THE TUBING SET HAD SNAPPED OR CRACKED. THE CUSTOMER CONTACT INDICATED THAT THE CLAVE SECONDARY PORT COULD BE BENT. IT WAS REPORTED THAT THE CLAVE SECONDARY PORT WAS NOT ACCESSED DURING THE THERAPY. IT WAS REPORTED THAT IT WAS SUSPECTED THAT THE SEMI-RIGID ADAPTER MIGHT HAVE CRACKED OR SNAPPED BEFORE USE; HOWEVER, THE CUSTOMER CONTACT INDICATED THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. NO SPECIFIC DETAILS WERE PROVIDED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173696 PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK