BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2962011 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00046
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT THAT THE SET LEAKED FROM THE UPPER SILICONE SEGMENT WAS CONFIRMED. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE SILICONE SEGMENT HAD A TEAR NEAR THE UPPER FITMENT. THE TEAR WAS MEASURED TO BE 0.1215 INCHES LONG. VISUAL EXAMINATION UNDER MICROSCOPE NOTED TWO CRUSH MARKS TO THE UPPER BLUE FITMENT. FUNCTIONAL TESTING WAS PERFORMED AND A LEAK WAS NOTED COMING OUT FROM THE SILICONE TUBING NEAR THE UPPER FITMENT. THE CAUSE OF THE LEAK WAS DUE TO A TEAR IN THE SILICONE SEGMENT. THE CAUSE OF THE TEAR IS UNKNOWN.

    Description of Event or Problem · 1

    AN UNEXPECTED RETURN OF A USED SET WAS RECEIVED WITH OTHER SAMPLES THAT WERE REPORTED TO HAVE LEAKED AT THE UPPER SILICONE SEGMENT DURING USE. NO FURTHER INFO COULD BE OBTAINED FROM THE CUSTOMER, SO THE SET IS PRESUMED TO HAVE LEAKED DURING USE. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33226 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0007 12095704

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN