BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APM/AIM PUMP SET W/C

    MDR report key: 1865174 · Received September 28, 2010

    Report

    Report Number
    9615050-2010-00176
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 30, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 80FPK AND HAS A 510K OF K941214. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IT USE, IT WAS REPORTED THAT WHILE THE PT WAS CHANGING CLOTHES, THE Y-SITE "FELL OFF" OF THE TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN 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 APM/AIM PUMP SET W/C UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK