BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3960496 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24414
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSFER SET WAS INVOLVED IN A CONNECTION ISSUE WITH A MINICAP WITH POVIDONE-IODINE SOLUTION. AFTER PERITONEAL DIALYSIS (PD) THERAPY, THE HOME PATIENT (HP) CAPPED THEIR TRANSFER SET. APPROXIMATELY 30 MINUTES LATER, THE MINICAP FELL OFF WHILE THE HP WAS SITTING DOWN. THE HP STATED THAT NO ISSUES WERE NOTICED WITH THE TRANSFER SET, WHICH HAD BEEN IN USE FOR APPROXIMATELY 3 MONTHS. THE INVOLVED TRANSFER SET DID NOT HAVE TO BE REPLACED, AND NO FURTHER DISCONNECTIONS OCCURRED WHEN OTHER MINICAPS FROM THE SAME BOX WHERE USED. THE HP CONFIRMED THAT THEY DID NOT DO ANYTHING THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE DISCONNECTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 4 FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439165 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 MINICAP WITH POVIDONE-IODINE SOLUTION ((B)(4))