BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM LC OL CNVRTBL P

    MDR report key: 2152490 · Received June 27, 2011

    Report

    Report Number
    9615050-2011-00460
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. A DEVICE FROM ONE OF TWO POSSIBLE LOT NUMBERS (PLOTS) 030155H AND 040265H IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 DELAY IN CRITICAL THERAPY FOLLOWING A LEAK. THE TUBING SET WAS TO BE USED TO DELIVER ALTEPLASE 100MG, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. IT WAS REPORTED THAT THE PT WAS DIAGNOSED WITH A STROKE AT A HOSPITAL AND WAS TRANSFERRED TO THE USER FACILITY FOR TREATMENT. IT WAS REPORTED THAT THE MEDICATION WAS TO BE DELIVERED WITHIN 30 MINS OF THE STROKE DIAGNOSIS. IT WAS REPORTED THAT THE AMOUNT OF TIME TO TRANSFER THE PT BETWEEN THE FACILITIES WAS 20 MINS. DURING PRIMING OF THE TUBING SET, A LEAK OF SOLUTION WAS NOTED COMING FROM AN UNSPECIFIED LOCATION. THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED WITHIN THE 30 MIN TIMEFRAME. ALTHOUGH, THERE WAS POTENTIAL FOR SERIOUS INJURY, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM LC OL CNVRTBL P 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1