BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER

    MDR report key: 2020849 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03214
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR WAS SUBMITTED ON (B)(4) 2011; HOWEVER, DUE TO A FAILURE TO RECEIVE THE 3 ACKNOWLEDGEMENTS, THIS MDR IS BEING RESUBMITTED ON (B)(4) 2011. THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL REGARDING POSSIBLE CONTAMINATION OF A TRANSFER SET, THE CAREGIVER (CG) REPORTED AN INCIDENT THAT HAPPENED BACK IN (B)(6) 2010 WITH THE HOME PATIENTS TRANSFER SET. THE CG STATED THAT THE TITANIUM PIECE ON THE TRANSFER WAS MAKING A HIGH PITCH WHISTLING SOUND AND PULLING AIR DURING THERAPY. THE CG WAS WITH THE HOME PATIENT (HP) IN THE HOSPITAL FOR TRAINING WHEN HE HEARD THE SOUND. THE CG CALLED THE PERITONEAL DIALYSIS REGISTERED NURSE AND SHE REPLACED THE TRANSFER SET ((B)(6) 2011). THE NOISE DISCONTINUED WITH THE NEW TRANSFER SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO