BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    MDR report key: 2503761 · Received March 19, 2012

    Report

    Report Number
    9615050-2012-00270
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 21, 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

    THIS DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 80FPA AND HAS A 510K OF K933326. 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 TO BE USED TO DELIVER AN UNSPECIFIED MEDIATION VIA A PLUM PUMP. IT WAS REPORTED THAT DURING PRIMING, THE TUBING SEPARATED FROM THE SECURE LOCK MALE ADAPTER OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED; HOWEVER, THERE WAS NO REPORTED DELAY IN CRITICAL THERAPY. 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 FRN HOSPIRA COSTA RICA LTD. NA 082015H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA