BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 2670231 · Received July 20, 2012

    Report

    Report Number
    9615050-2012-00823
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING THE DEVICE DELIVERED A MEASURED VOLUME OF 19.9ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/-1ML (+/-5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF LAST PROGRAMMING ON THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2012 AT 1532, LINE B WAS PROGRAMMED IN THE CONCURRENT MODE TO DELIVER AN UNSPECIFIED ANTIBIOTIC 100ML, AT A RATE OF 25ML/HR., WITH A VTBI (VOLUME TO BE INFUSED) OF 100ML, FOR A DURATION OF 4 HRS, AND THE DELIVERY WAS STARTED. BETWEEN 1557 AND 1600, THE DEVICE ALARMED N186 (DISTAL OCCLUSION) 3 TIMES, AND THE DELIVERY WAS RESTARTED 3 TIMES. AT 1602, THE DEVICE WAS TURNED OFF. THIS REPORTED REPRESENTS ALL THE INFORMATION KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT REC'D LESS MEDICATION THAN INTENDED. AT 2000, LINE B OF THE DEVICE WAS PROGRAMMED TO DELIVER ZOSYN 100ML, AT A RATE OF 25ML/HR, FOR A DURATION OF 4 HRS, AND THE DELIVERY WAS STARTED. AFTER APPROX 5 HRS, IT WAS REPORTED THAT THE NURSE NOTED ONLY 85ML OF THE ZOSYN HAD BEEN DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. 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 ADD'L 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 10 YR SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #20677,