BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2243283 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12050
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 31, 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 COMPLAINT COULD NOT BE CONFIRMED IN THE LAB SINCE THERE WAS NO SAMPLE RETURNED. A BATCH REVIEW WAS NOT POSSIBLE SINCE THE LOT IS UNKNOWN. SINCE NO PRODUCT DEFECT EXPOSURE COULD BE IDENTIFIED, NO ROOT CAUSE CAN BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS IS BEING INVESTIGATED THROUGH CAPA. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE ADAPTOR IS UNKNOWN. SINCE THE DEVICE IS UNKNOWN, A 510K NUMBER CANNOT BE PROVIDED. THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HP STATED SHE WAS IN THE HOSPITAL BECAUSE HER ADAPTER FELL OFF. THE HP DESCRIBED THE ADAPTER AS THE SILVER TUBE BETWEEN THE CATHETER AND TRANSFER SET. THE SURGEON REPLACED THE TRANSFER SET ON (B)(6) 2011. THERE WAS NO PATIENT INJURY. (B)(4) CONTACTED THE PERITONEAL DIALYSIS NURSE (RN). THE RN STATED THAT THE HOME PATIENT (HP) WAS USING A TITANIUM ADAPTER, BUT WAS UNSURE OF THE MANUFACTURER.

    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 MI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR HOMECHOICE