BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUMSET 2 CLAVES 272CM NDEHP

    MDR report key: 3050414 · Received April 8, 2013

    Report

    Report Number
    9615050-2013-00620
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 15, 2013
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. 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 A 510K OF K982159. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PT NOTED THE PILLOW WAS DAMP. IT WAS REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM AN UNSPECIFIED LOCATION OF THE TUBING SET; HOWEVER, DURING A VISUAL EXAMINATION OF THE TUBING SET, DROPLETS OF SOLUTION WERE NOTED ON THE EXTERIOR OF THE TUBING SET. IT WAS REPORTED THAT THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF THE SOLUTION LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142475 PRIMARY PLUMSET 2 CLAVES 272CM NDEHP UNK FRN HOSPIRA COSTA RICA LTD. NA 190935H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM PUMP, LIST # UNK, SN # UNK