BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP

    MDR report key: 17836831 · Received September 28, 2023

    Report

    Report Number
    1416980-2023-04916
    Event Type
    Death
    Date Received
    September 28, 2023
    Report Date
    March 1, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE ¿ THE PATIENT EXPERIENCED PERITONITIS IN (B)(6) 2023. D4: CATALOGUE # AND D4: LOT # - THE PATIENT USED UNSPECIFIED MINICAPS (PRODUCT CODE: UNKNOWN, LOT: ASKED-UNKNOWN) FROM THE RECALL FA 2023-003. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B2, H1, H6 AND H10. B5: UPON FOLLOW UP IT WAS REPORTED THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO DEATH OR AT THE TIME OF DEATH. H10: THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT USED AN UNSPECIFIED QUANTITY OF MINICAPS THAT CONTAINED AN INADEQUATE VOLUME OF IODINE SOLUTION ON THE SPONGE WHICH RESULTED IN PERITONITIS AND SEPTIC SHOCK. ON AN UNSPECIFIED DATE, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS TREATED FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2173782 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H NI.