BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2821628 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04205
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION ABOUT ANY PRODUCT PROBLEM IS AVAILABLE, NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED PRODUCT SURVEILLANCE TO REPORT LOOSE MINICAPS ON THE TRANSFER SET. 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 OF MINICAPS AND SOME MINICAPS FROM THE CLINIC BUT THE ALL THE MINICAPS WERE FOUND TO BE LOOSE AND CONTINUED TO BE FROM (B)(6) 2012 (THIS REPORT IS COVERING THE (B)(6) 2012 OCCURRENCE). THE CG SAID THE HP WENT TO THE CLINIC ON (B)(6) 2012 TO HAVE THE TRANSFER SET CHANGED OUT AGAIN. 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)(6) 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. 5 OF 13 TRANSFER SET - CONNECTION ISSUE. (B)(4) - MINICAP SIDE.

    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