BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ SPANISH DEVIC

    MDR report key: 2854541 · Received November 29, 2012

    Report

    Report Number
    9615050-2012-01439
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE DEVICE WITH NO DEVICE ALARM. AT AN UNSPECIFIED TIME, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER ADRENALINE 1MG/24ML, AT A RATE OF 0.9ML/HR, FOR A DURATION OF 24 HOURS, AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE PATIENT WAS HYPOTENSIVE. NO SPECIFIC BLOOD PRESSURE VALUES WERE REPORTED. AT THAT TIME, THE NURSE NOTED THAT APPROXIMATELY 10CM PAST THE CASSETTE IN THE TUBING DISTAL TO THE DEVICE, THERE WERE SEVEN SOLID AIR SEGMENTS THAT MEASURED 2CM IN LENGTH, WITH NO DEVICE ALARM. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING IF AIR WAS DELIVERED TO THE PATIENT AND IF THE DEVICE WAS REMOVED FROM CLINICAL SERVICE AND THERAPY WAS RESUMED USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ SPANISH DEVIC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO ADRENALINE, MANUFACTURER UNK| PULM A+ SOFTWARE MODULE, LIST #12097, SN0075266076| PLUMSET LIST # L218, LOT #130255H