BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET, HI-FLOW T-CONNECTOR

    MDR report key: 2910596 · Received December 3, 2012

    Report

    Report Number
    9616066-2012-00874
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A CUSTOMER IS HAVING PROBLEMS WITH A T-CONNECTOR SET. A NURSE REPORTED THAT THE LUER END WITH THE WHITE CAP, DISTAL TO THE PATIENT IS CRACKING, SPLITTING, AND LEAKING. THE NURSE REPORTED THAT SHE WILL SEE EITHER BLOOD OR IV FLUIDS LEAKING FROM THE LUER END OF THE EXTENSION WHERE IT IS SPLIT OR CRACKED. THIS IS HAPPENING FREQUENTLY AND SOME PATIENTS HAVE LOST IVS DUE TO THE BACKFLOW OF BLOOD TO THE CRACKED AREA. WHEN THIS OCCURS AND IF THE IV IS STILL FLOWING THEY CHANGE OUT TO A NEW T-CONNECTOR EXTENSION SET. THE NURSE REPORTED THAT THEY PUT A CLAVE NEEDLELESS CONNECTOR ON THE LUER END AND THAT THEY ARE NOT SWABBING THIS SITE PRIOR TO PLACING THE CLAVE. SHE STATES THAT THEY USE ALCOHOL SWABS TO CLEAN THE PORT PRIOR TO DRAWING BLOOD OR STARTING IV FLUIDS. ALSO, SHE REPORTED THAT SOME PATIENTS MAY HAVE RECEIVED POWER INJECTIONS THROUGH THE SMARTSITE VALVE CLOSEST TO THE PATIENT BUT THAT THE CRACKING AND SPLITTING EVENTS ARE OCCURRING ON SEVERAL PATIENTS THAT HAVE NOT RECEIVED A POWER INJECTION. THEY WERE INFORMED THAT THIS SET IS NOT RATED FOR USE WITH POWER INJECTORS AND SHE REPORTED THAT THEY WILL STOP THE PRACTICE AND ORDER AN APPROPRIATE SET FOR THAT USE. NO PATIENT HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS EXTENSION SET, HI-FLOW T-CONNECTOR FPA CAREFUSION CORPORATION 20043E 12105033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CLAVE NEEDLELESS CONNECTOR: MODEL/LOT # UNKNOWN