BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    MDR report key: 2751941 · Received September 17, 2012

    Report

    Report Number
    9615050-2012-01097
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 22, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K052052. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. 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 AIR IN THE TUBING, DISTAL TO THE CASSETTE. ON AN UNSPECIFIED DATE, THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUME OF BUBBLES WERE NOTED IN THE TUBING, DISTAL TO THE DISTAL PREPIERCED Y-SITE OF THE TUBING SET. IT WAS REPORTED THE BUBBLES WERE NOTED, DESPITE FLUSHING THE Y-SITE WITH AN UNSPECIFIED SOLUTION. 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 REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUMSET PP YSITE 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA 162375H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK