BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 15977178 · Received December 14, 2022

    Report

    Report Number
    1416980-2022-06864
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Report Date
    January 18, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412090078
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO A1: PATIENT IDENTIFIER: (B)(6) (PREVIOUSLY SUBMITTED AS (B)(6)). CORRECTION MADE TO G1: DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - DOMINICAN REPUBLIC (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE - HAINA). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 1: CARRETERA SANCHEZ KM 18.5 (PREVIOUSLY SUBMITTED AS PIISA INDUSTRIAL PARK ANTIGUA). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 2: PARQUE INDUSTRIAL ITABO, PIISA (PREVIOUSLY SUBMITTED AS CARRETERA SANCHEZ KM 18 1/2). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE SUPPLY LINE OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE AND THE SUPPLY BAG. THE CONNECTION ISSUE WAS FURTHER DESCRIBED AS, ¿SOMETIMES THE CONNECTORS ON THE LINES DID NOT HAVE THREADS AND SOMETIMES WHEN TWISTING TO CONNECT THEY WOULD HEAR A SNAPPING NOISE¿ AND ¿WHEN THEY TRIED TO CONNECT, IT WOULD JUST SPIN AND NOT ACTUALLY CATCH¿. THIS OCCURRED DURING SETUP FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO 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
    2023843 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA DR22G04017 00085412090078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown