BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+3 V11.51 REFR

    MDR report key: 3023101 · Received February 26, 2013

    Report

    Report Number
    9615050-2013-00283
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2013 AT 1344, THE DEVICE WAS TURNED ON AND THE SETTINGS WERE CLEARED. AT 1346, LINE A ON CHANNEL 1 WAS PROGRAMMED TO DELIVER AT A RATE OF 565ML/HR, WITH A VTBI (VOLUME TO BE DELIVERED) OF 556ML/HR, FOR A DURATION OF 1 HOUR, AND THE DELIVERY WAS STARTED. AT 1439, THE DEVICE ALARMED N101 (NO ACTION ALARM) AND WAS SILENCED. AT 1440, DELIVERY WAS STOPPED WITH A VOLUME INFUSED (VI) OF 499.8ML. AT 1442, THE DEVICE ALARMED N101 AND WAS SILENCED. AT 1443, THE DELIVERY WAS REPROGRAMMED FOR A VTBI OF 50ML, FOR A DURATION OF 5 MINUTES, AND THE DELIVERY WAS RESTARTED. AT 1448, THE DEVICE ALARMED N161 (LINE A VTBI COMPLETE), KEEP VEIN OPEN (KVO) STARTED AT 1ML/HR, ALARM WAS SILENCED, DELIVERY WAS REPROGRAMMED FOR A VTBI OF 50ML, FOR A DURATION OF 5 MINUTES AND THE DELIVERY WAS RESTARTED. AT 1454, THE DEVICE ALARMED N161, KVO STARTED AT 1ML/HR, AND THEN ALARMED N232 (PROXIMAL AIR A, BACKPRIME). AT 1455, THE DEVICE WAS TURNED OFF. THE REVIEW OF THE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. 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 DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE. AT AN UNSPECIFIED TIME, CHANNEL 1 OF THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CHEMOTHERAPY MEDICATION, AT A RATE OF 565ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 565ML, AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE CHECKED THE DEVICE AND NOTED THERE WAS STILL A REMAINING DURATION OF 10 MINUTES. THE NURSE REPORTED THAT WHEN WALKING AWAY FROM THE PT, THE DEVICE SOUNDED AN UNSPECIFIED ALARM. AT THE TIME, THE NURSE NOTED THE DEVICE DISPLAYED A KVO (KEEP VEIN OPEN) RATE OF 1ML/HR INSTEAD OF 565ML/HR, AND THERE WAS 65.2ML REMAINING IN THE CHEMOTHERAPY CONTAINER. AT THAT TIME, THE NURSE REPROGRAMMED THE DEVICE TO DELIVER THE REMAINING MEDICATION WITH A DURATION OF 10 MINUTES AND THE DELIVERY WAS RESTARTED. AFTER THE DELIVERY WAS COMPLETE, 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 INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83131 PLUM A+3 V11.51 REFR 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR