BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 2003284 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02552
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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

    THIS REPORT ADDRESSES PRODUCT QUANTITY 3 OF 30. THE HOME PATIENT (HP) REPORTED TO CORPORATE PRODUCT SURVEILLANCE THAT THE ENTIRE BOX OF PATIENT EXTENSION LINES WERE DAMAGED, AND SEVERAL WERE CUT. THE HP CALLED TO REPORT THIS ISSUE WHILE DRIVING TO SEE THE REGISTERED NURSE (RN) TO GET ADDITIONAL SAMPLES AND TO REPORT MISSED THERAPY AS A RESULT. THE HP STATED SHE WAS ABOUT TO CONNECT TO BEGIN THERAPY WHEN SHE NOTICED THAT THE TUBING WAS LEAKING (THE HP CONFIRMED THE BLUE CAP WAS STILL ON THE PATIENT LINE). SHE STATED SHE THEN DISCOVERED THE REMAINING SAMPLES WERE DAMAGED. THE HP STATED SHE HAD DISCARDED ALL THE PRODUCT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10J29080

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR