BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2221947 · Received August 17, 2011

    Report

    Report Number
    2016493-2011-00475
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVAL HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT WHEN A SECOND INFUSION OF LEVOQUIN (500ML BAG) SHOULD HAVE FINISHED, THE BAG FOUND HALF FULL. A LARGE BUBBLE WAS FOUND BELOW THE PUMP (THE AMOUNT OF AIR: ONE INCH OF AIR, ONE INCH OF FLUID AND THEN ANOTHER INCH OF AIR) AND THE PUMP DID NOT ALARM. THE PRIMARY WAS 1000ML BAG, ONE HANGER WAS USED TO LOWER THE PRIMARY. CUSTOMER STATED THEIR IV POLES ARE ALREADY LOWERED ON ONE SIDE, SO ONE HANGER IS ALL THAT IS REQUIRED. THE PC UNIT WAS NOT SEQUESTERED. THE PUMP MODULE HAS BEEN RETURNED FOR INVESTIGATION. EVENT TUBING WAS NOT SAVED. MATERIALS MANAGEMENT REPORTED THAT THE PRIMARY SET THEY USE IS MODEL 2420-0500 AND THE SECONDARY IS MODEL 72213N. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 2420-0500| LOT UNK| SECONDARY ADMINISTRATION SET: MODEL 72213N,| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMINISTRATION SET: