BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1991300 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01973
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF A SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES (GTS) NEEDING ASSISTANCE. THE HP WAS HAVING A PROBLEM WITH THEIR TRANSFER SET AND WANTED TO KNOW THE EMERGENCY CONTACT INFORMATION FOR THEIR NURSE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT BAXTER DID NOT HAVE THE NUMBER AND TO CONTACT THEIR DOCTOR. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OF MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE WITH THE HP REGARDING THE REPORTED PROBLEM. THE HP STATED HE DOES NOT RECALL THE EVENT AND STATED HE IS DOING FINE. HE STATED HIS TRANSFER SET WAS WORKING JUST FINE AND HAS RESUMED THERAPY ON THE CYCLER. THE NURSE WAS CONTACTED REGARDING THE REPORTED PROBLEM AND SHE STATED THE HP ENDED UP HAVING TO CHANGE OUT HIS TRANSFER SET DUE TO IT BEING CRACKED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR