BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3873291 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18997
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H13L30040 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS RECEIVED FOR EVALUATION. SAMPLE ANALYSIS OF THE RECEIVED SAMPLE VERIFIED THE REPORTED EVENT. SAMPLE EVALUATION VERIFIED AND DUPLICATED THE REPORTED EVENT WITH A LEAK NOTED FROM CUT IN THE SHEETING NEAR WELD ON ONE OF THE SAMPLES. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. A CAPA WAS OPENED TO INVESTIGATE THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE AUTOMATED PD SET WITH CASSETTE WAS LEAKING. THIS OCCURRED DURING DRAIN. THE REPORTER STATED THAT THE LEAK WAS COMING FROM THE TOP OF THE CASSETTE ON THE STRAIGHT SIDE, AND THAT THEY SAW A ¿DISTINCT HOLE.¿ THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349314 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13L30040

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE