BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19773594 · Received July 18, 2024

    Report

    Report Number
    1416980-2024-03710
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 24, 2024
    Report Date
    September 17, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D3: DEVICE MANUFACTURER NAME: BAXTER INTERNATIONAL INC. PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION. THE CUSTOMER RETURNED A SAMPLE WITH PRODUCT CODE 5C4483 FOR EVALUATION. THE DEVICE WAS RETURNED WITH A PATIENT CONNECTOR ATTACHED TO THE FEMALE CONNECTOR. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY. THERE WAS EVIDENCE ON THE FEMALE CONNECTOR INDICATING AN INSERT CHIP WAS PRESENT. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS RELATED TO INADEQUATE SOLVENT APPLICATION BETWEEN THE FEMALE CONNECTOR, INSERT CHIP, AND MAIN BODY DURING THE MANUFACTURING PROCESS. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS ¿BLUE PART CAME OUT OF THE HOUSING¿. THIS OCCURRED DURING USE OF THE DEVICE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS UNABLE TO DISCONNECT FROM THE CASSETTE AND HAD TO CUT THE PATIENT LINE TO DISCONNECT FROM THE CYCLER. THE TRANSFER SET WAS REPLACED. 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
    1556582 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H23C29022 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male CASSETTE