BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3873240 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18989
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF THE SAMPLE BECOMES AVAILABLE FOR EVALUATION OR ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE AND A DAMAGED LUER/HEAT SEAL BEAD WAS FOUND. LEAK TESTING WAS PERFORMED AND VERIFIED A LEAK FROM THE PATIENT LINE (HEAT SEAL AREA). THE REPORTED ISSUE WAS VERIFIED VIA THE SAMPLE EVALUATION, AND THE CAUSE WAS IDENTIFIED TO BE THE DAMAGED LUER/HEAT SEAL BEAD. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A LEAK DURING THE THIRD DRAIN OF THERAPY WITH A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THE HP OBSERVED COMING FROM THE PATIENT LINE OF THE CASSETTE. THERE WAS A SMALL SLIT IN THE TUBING NEAR THE PATIENT CONNECTOR WHICH WAS FURTHER DESCRIBED AS HAVING A BURNT APPEARANCE NEAR WHERE THE PATIENT LINE CONNECTS TO THE CATHETER. THE HP RECEIVED UNKNOWN PROPHYLACTIC ANTIBIOTICS OF UNKNOWN TYPE OR STRENGTH. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349103 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE