BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 3410725 · Received September 20, 2013

    Report

    Report Number
    9615050-2013-03217
    Event Type
    Malfunction
    Date Received
    September 20, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 21, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AT A RATE OF 40 ML/HR, WITH A VTBI (VOLUME TO BE INFUSES) OF 1060 ML, FOR A DURATION OF 24 HOURS, AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE NURSE NOTED THE CONTAINER WAS EMPTY; HOWEVER, THE DEVICE DISPLAY INDICATED A VOLUME INFUSED OF 610 ML. THE NURSE REPORTED THE DEVICE DID NOT DISPLAY A "VTBI COMPLETE" MESSAGE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476814 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #12097