BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 1934174 · Received December 8, 2010

    Report

    Report Number
    2921482-2010-00964
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 17, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 20.1 ML FROM AN EXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20 ML +/- 2 ML (+/- 10%). A CALIBRATED TUBING SET WAS USED FOR TESTING PER THE DEVICE RELEASE SPECIFICATIONS. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. UPON INITIAL POWER ON THE DEVICE DURING TESTING AND INVESTIGATION, THE PRIMARY LINE DISPLAYED A PROGRAMMED RATE OF 125 ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 950 ML AND THE SECONDARY LINE DISPLAYED A PROGRAMMED RATE OF 999 ML/HR WITH A VTBI OF 64.5 ML AND A TOTAL VOLUME DELIVERED OF 10.8 ML. THE TECHNOLOGY OF THE ACCLAIM ENCORE PUMP LIST #12237 DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMING SETTINGS. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVERED LACTATED RINGERS 1000 ML, AT A RATE OF 125 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 1000 ML, AND THE DELIVERY WAS STARTED. ON (B)(6) 2010 AT 0900, THE PT WAS TRANSFERRED TO THE LABOR AND DELIVERY DEPARTMENT IN PREPARATION FOR DELIVERY. AT THIS TIME, THE PUMP WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF AMPICILLIN 2 GM/100ML, AT A RATE OF 200 ML/HR, FOR A DURATION OF 30 MINS, AND THE DELIVERY WAS STARTED. AT THIS TIME, THE NURSE STATED THAT THE PUMP WAS "MAKING THE NOISE LIKE IT WAS INFUSING BUT IT WASN'T DRIPPING." THE NURSE POWERED THE PUMP OFF, UNPLUGGED AND REPLUGGED THE PUMP INTO THE AC POWER OUTLET. IT WAS REPORTED THAT THE PUMP WAS THEN POWERED BACK ON. THE PUMP WAS REPROGRAMMED WITH THE PREVIOUS SETTING, THE PRIMARY CONTAINER WAS LOWER BELOW THE SECONDARY CONTAINER AND DELIVERY WAS RESTARTED. THE NURSE REPORTED THAT THE PUMP, "WAS STILL RUNNING WITH THE DISPLAY INCREMENTING DOWN BUT THERE WERE NO DROPS." THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT OR TO THE INFANT. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE 2.25 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR PRIMARY PIGGYBACK IV SET: LIST #12664, LOT #UNK| SECONDARY IV SET: LIST #14260, LOT #UNK