BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2831600 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05075
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE LOT NUMBER IS UNKNOWN AND A BATCH REVIEW WILL NOT BE PERFORMED. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE EVALUATION OF THE RETURNED SAMPLE DID NOT DUPLICATE THE ALLEGED ISSUE.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED PRODUCT SURVEILLANCE TO REPORT LOOSE MINICAPS ON THE TRANSFER SET ON (B)(6) 2012. THE CG STATED THAT THE HOME PATIENT (HP) WENT TO THE CLINIC ON (B)(6) 2012 TO HAVE HIS 6 MONTH TRANSFER SET CHANGED OUT. THE CG SAID THAT WHEN THE HP WENT TO REMOVE THE MINICAP FOR THERAPY THAT NIGHT IT WAS LOOSE. THE HP TRIED 2 DIFFERENT LOT NUMBERS MINICAPS AND SOME MINICAPS FROM THE CLINIC. THE CG SAID THE HP WENT TO THE CLINIC ON (B)(6) 2012 TO HAVE THE TRANSFER SET CHANGED OUT AGAIN. THE CG SAID THAT THE MINICAPS STILL APPEAR TO BE LOOSE ON THE NEW TRANSFER SET. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) REGISTERED NURSE (RN) ON (B)(4) 2012 REGARDING THE LOOSE MINICAPS. THE RN SAID THAT SHE HAD DISCARDED THE TRANSFER SET THAT SHE HAD CHANGED OUT. THE RN DID NOT HAVE A LOT NUMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 62 YR HOMECHOICE