BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    MDR report key: 2505481 · Received March 16, 2012

    Report

    Report Number
    9615050-2012-00266
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM THE SAME LOT 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 80FRN 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AS UNSPECIFIED MEDICATION VIA A PLUM PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A NEEDLELESS VALVE CONNECTOR WAS CONNECTED TO THE SECONDARY PORT OF THE CASSETTE OF THE PRIMARY TUBING SET OF A SECONDARY DELIVERY OF AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME, SOLUTION LEAKED FROM THE LUER CONNECTION OF THE NEEDLELESS VALVE CONNECTOR AND THE SECONDARY PORT OF THE CASSETTE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. 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 PRIMARY PLUMSET PP YSITE 272CM NDEHP UNK FPA HOSPIRA COSTA RICA LTD. NA 101095G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MFR ICU MEDICAL| CLAVE CONNECTOR: LIST #011-C1000, LOT #2077930,| SECONDARY TUBING SET: LIST #0F056, LOT # 102165G