BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 14625756 · Received June 7, 2022

    Report

    Report Number
    1416980-2022-02955
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 14, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412030531
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: UPON FOLLOW UP IT WAS REPORTED FIVE DAYS AFTER THE LEAK OCCURRED, THE PATIENT EXPERIENCED STOMACH CRAMPS. TWO DAY S LATER, THE PATIENT EXPERIENCED AN UNSPECIFIED BACTERIAL INFECTION MANIFESTED BY CLOUDY EFFLUENT. THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE DURING HOSPITALIZATION, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS THERAPY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND SHOWED THE FEMALE SHROUDED CONNECTOR WAS BROKEN OFF FROM THE SUPPLY LINE ASSEMBLY. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SUPPLY LINE LUER CONNECTOR OF THE HOMECHOICE CASSETTE ¿BROKE OFF¿ AND DISCONNECTED FROM THE SUPPLY LINE TUBING WHICH RESULTED IN A LEAK. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. THIS ISSUE WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122718 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA S22C15053 00085412030531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H HOMECHOICE DEVICE.| UNSPECIFIED PD SOLUTION.