BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVERTBL I.V. DUAL CHANNEL HSP

    MDR report key: 2906376 · Received December 18, 2012

    Report

    Report Number
    9615050-2012-01546
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    January 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM THE SAME LOT WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K052052. 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 NO FLOW. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE AT A RATE OF 300 ML/HR, VIA A PLUM PUMP. THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS PRIMED WITHOUT ANY DIFFICULTY. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE PT'S IV CANNULA AND REPORTEDLY THE SOLUTION STARTED TO FLOW. AFTER AN UNSPECIFIED VOLUME OF SOLUTION WAS DELIVERED, NO FLOW OF SOLUTION WAS NOTED. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. 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
    1 CONVERTBL I.V. DUAL CHANNEL HSP UNK MEA HOSPIRA COSTA RICA LTD. NA 191145H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ PUMP LIST #UNK, SN# UNK