BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 2682234 · Received August 1, 2012

    Report

    Report Number
    9615050-2012-00868
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 5, 2012
    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
    IN, US
    Reporter Occupation
    NURSE

    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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED LESS MEDICATION THAN INTENDED. AT APPROXIMATELY 0000, LINE B OF THE DEVICE WAS PROGRAMMED TO DELIVER ZOSYN 100ML, AT A RATE OF 25 ML/HR, FOR A DURATION OF 4 HRS, AND THE DELIVERY WAS STARTED. THE NURSE REPORTED THAT THE DELIVERY WAS COMPLETE IN APPROXIMATELY 5 1/2 HRS INSTEAD OF THE EXPECTED 4 HR DURATION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SAME DEVICE WAS PROGRAMMED TO DELIVER THE NEXT CONTAINER OF ZOSYN, AND THE DELIVERY WAS STARTED. THE NURSE REPORTED THAT THE DELIVERY TOOK LONGER TO COMPLETE THAN THE EXPECTED. NO SPECIFIC INFO WAS PROVIDED REGARDING THE EXPECTED AND ACTUAL DURATION OF THE SECOND ZOSYN DELIVERY. AT THAT TIME, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR PLUM A+ SOFTWARE MODULE: LIST#20677, SN (B)(4)