BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2855064 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06357
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE U.S. AND DOES NOT HAVE A 510K NUMBER. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER IN REFERENCE TO THE USE ERROR; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED THAT THERE WAS A BREAK IN ASEPTIC TECHNIQUE, WHICH IS A USE ERROR THAT CAN CAUSE PERITONITIS OR POTENTIAL CONTAMINATION. THE CAUSE WAS UNDETERMINED. A LABELING REVIEW WAS PERFORMED IN RESPONSE TO THE USER ERROR IN THIS COMPLAINT, AND THE LABELING WAS FOUND TO BE ADEQUATE. 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CONNECTION ISSUE RELATED TO THE TITANIUM ADAPTER. THIS PROBLEM WAS FOUND DURING USE. THE HOME PATIENT (HP) REPORTED A DISCONNECTION BETWEEN THE TRANSFER SET AND TITANIUM ADAPTER. THE HP RECONNECTED THE TRANSFER SET TO THE TITANIUM ADAPTER AND CONTINUED TREATMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR TITANIUM ADAPTER