BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM LS PRIMARY

    MDR report key: 1873470 · Received September 20, 2010

    Report

    Report Number
    9615050-2010-00173
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 25, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. NO. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED ARTERIAL CATHETER AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED SOLUTION. THE CUSTOMER CONTACT REPORTED THAT AFTER THE THERAPY WAS STARTED, THE NURSE NOTED A DROP OF THE UNSPECIFIED SOLUTION AT THE PROXIMAL Y-SITE. AT THAT TIME, THE NURSE MOVED THE TUBING SET AND NOTED THE TUBING HAD SEPARATED FROM THE ARM OF THE PROXIMAL Y-SITE. AN UNSPECIFIED VOLUME OF BLOOD THAT WAS DESCRIBED AS "A VERY SMALL AMOUNT" BACKED UP IN THE TUBING. THE TUBING SET WAS CLAMPED. 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 REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM LS PRIMARY 80FRN FRN HOSPIRA COSTA RICA LTD. NA 790195H

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA