BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2082560 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00168
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 04/27/2011. (B)(4). THE CUSTOMER'S REPORT OF THE SILICONE TUBING BALLOONING WAS CONFIRMED, HOWEVER, UNABLE TO DETERMINE IF THE BALLOONING OCCURRED ON PRIMING AS REPORTED. CRUSH MARKS WERE NOTED ON THE UPPER FITMENT SO SET WAS MOST LIKELY LOADED IN A PUMP MODULE, WHICH CONFERS WITH CUSTOMER STATEMENT THAT SET WAS PLACED IN A DEVICE. THE BALLOONED SET WAS LOADED IN A PUMP AND A FUNCTIONAL TEST WAS PERFORMED WHICH PRODUCED AN OCCLUDED FLUID SIDE ALARM IN LESS THAN ONE MINUTE. THE DOOR TO THE PUMP WAS OPENED AND THE EARLIER NOTED BALLOONED SECTION WAS THEN NOTED TO BE PARTIALLY BALLOONED. FLUID WAS ALLOWED TO FLOW THROUGH THE SET VIA GRAVITY; THE BALLOON IN THE SILICONE TUBING DEFLATED DUE TO THE RELIEF IN PRESSURE. NO FURTHER BALLOONING OF THE SILICONE TUBING OR ANY LEAK WAS OBSERVED. THE SET WAS LOADED BACK INTO THE DEVICE AND INFUSION COMPLETED WITH NO FURTHER ALARMS NOTED. A PRESSURE TEST WAS PERFORMED; THE SILICONE TUBING NEAR THE UPPER FITMENT BALLOONED AT LESS THAN 5PSI AND NO LEAKS WERE OBSERVED DURING A PRESSURE TEST AT 30PSI FROM ANYWHERE ON THE SET. THE SET WAS PRIMED AND FLUID WAS ALLOWED TO FLOW THROUGH THE SET VIA GRAVITY; NO FURTHER BALLOONING OF THE SILICONE TUBING WAS OBSERVED. TESTING HAS SHOWN THAT EVEN WITH A COMPROMISED SILICONE SEGMENT, THE PRESSURES INVOLVED WITH NORMAL PRIMING ARE NOT HIGH ENOUGH TO CAUSE BALLOONING. THE ROOT CAUSE OF THE PUMPING SEGMENT BALLOONING DURING PRIMING AND THE INABILITY TO INFUSE THROUGH THE SET WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PUMPING SEGMENT BALLOONED UPON PRIMING. WHEN SET WAS PLACED INTO THE PUMP, IT WOULD NOT INFUSE. NO PATIENT CONTACT WITH PRODUCT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0007 11025693

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE, SERIAL # UNKNOWN| ALARIS PC UNIT, SERIAL # UNKNOWN