BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140556 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00318
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 31, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K951922
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S EXPERIENCE OF A DISTAL LUER LOCK NUT BREAKING OFF WAS CONFIRMED. VISUAL INSPECTION OF THE SET SHOWED THE LUER LOCK NUT WAS NOT ATTACHED TO THE LUER LOCK. THE LUER LOCK NUT WAS NOT RECEIVED. NO OTHER ANOMALIES WERE OBSERVED WITH THE RETURNED SET AND NO DAMAGE WAS SEEN ON THE MALE LUER. PREVIOUS INVESTIGATIONS IDENTIFIED THAT THE LUER SEPARATION WAS DUE TO A MOLDING ISSUE. IN PARTICULAR, THE AREA OF THE MOLD THAT CREATES THE STEP ON THE LUER THAT HOLDS THE NUT IN PLACE. THE SUPPLIER FOUND THAT ALTHOUGH THE DISCONNECTION STRENGTHS WERE FOUND TO BE WITHIN SPECIFICATION, SOME VALUES WERE AT THE SPECIFICATION LIMITS. CHANGES WERE MADE TO THE TOOL AND TRACTION TEST EVALUATIONS SHOWED THAT THESE CHANGES RESULTED IN AN INCREASE OF THE AVERAGE TRACTION FORCE TO DISCONNECT THE NUT FROM THE LUER. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EXPERIENCE WAS IDENTIFIED AS A SUPPLIER ISSUE. THE TOOL USED TO CREATE THE STEP ON THE LUER WAS FOUND TO YIELD PRODUCT THAT WERE AT THE LIMITS OF DISCONNECTION STRENGTH.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE END TIP BROKE OFF WHILE PUTTING IT TO THE STOPCOCK. NO PT/USER HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2125-0500 10105696

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK