BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1935505 · Received December 15, 2010

    Report

    Report Number
    9616066-2010-00368
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 12/15/2010. (B)(4). THE SET WAS RECEIVED FOR INVESTIGATION IN 2 SEPARATE SECTIONS AND THE SILICONE SEGMENT SEPARATING FROM THE LOWER FITMENT WAS CONFIRMED. THE O-RING THAT SECURES THE SILICONE TUBING TO THE LOWER FITMENT WAS NOT PRESENT, HOWEVER, AN INDENTATION ON THE SILICONE TUBING SUGGESTS THAT THE O-RING WAS PRESENT AT SOME TIME. CRUSH MARKS WERE NOT OBSERVED ON THE LOWER FITMENT AND THE SILICONE TUBING SHOWS NO SIGNS OF STRETCHING OR BALLOONING. THE ROOT CAUSE OF THE SILICONE TUBING SEPARATION WAS NOT IDENTIFIED. THE LOT NUMBER IS UNK, HOWEVER, THE SMARTSITE LASER NUMBER INDICATES THE SET WAS BUILT BETWEEN (B)(4) 2010 AND (B)(4) 2010. EXPIRATION DATE IS BETWEEN 06/01/2013 AND 07/01/2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SILICONE SEGMENT SEPARATED FROM THE TUBING AT THE END WHERE IT CONNECTS TO THE LOWER FITMENT. THE O-RING CAME APART AND IS MISSING, AND THE END OF THE SILICONE SEGMENT APPEARS DILATED. THE REPORTER DOESN'T KNOW FOR SURE, BUT STATES THE SEPARATION LIKELY HAPPENED WHEN TRANSFERRING THE PT FROM THE OPERATING ROOM TABLE TO THE BED, STATING THERE IS TOO MUCH URGENT ACTIVITY AT THAT TIME AND THEY CAN'T STOP TO MAKE SURE ALL THE LINES ARE NOT SNAGGING ON SOMETHING. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK