BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 20050364 · Received August 23, 2024

    Report

    Report Number
    1416980-2024-04476
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). E1: ADDITIONAL INITIAL REPORTER PHONE NO. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO B5: THE NURSE HAD A DIFFICULT TIME DISCONNECTING THE PATIENT LINE OF THE AMIA (PREVIOUSLY SUBMITTED AS HOMECHOICE) CASSETTE FROM THE FEMALE CONNECTOR. CORRECTION MADE TO D3: DEVICE MANUFACTURER NAME: BAXTER INTERNATIONAL INC. (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION). CORRECTION MADE TO D10: CONCOMITANT PRODUCT: AMIA CASSETTE (PREVIOUSLY SUBMITTED AS HOMECHOICE CASSETTE). CORRECTION MADE TO H4 DEVICE MANUFACTURE DATE: 05/27/2024 (PREVIOUSLY SUBMITTED AS NI). THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED SEPARATION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DETERMINED TO BE MANUFACTURING RELATED DUE TO AN INADEQUATE SOLVENT BOND BETWEEN THE FEMALE CONNECTOR, INSERT CHIP, AND MAIN BODY. THE FEMALE CONNECTOR WAS CONNECTED AND DISCONNECTED WITH NO ISSUES NOTED; THEREFORE THE REPORTED CONNECTION ISSUE TO THE FEMALE CONNECTOR WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED 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 (NAVY BLUE) AND MAIN BODY (LIGHT BLUE) OF THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS ¿TWIST- NAVY BLUE END TURNING AWAY FROM LIGHT BLUE END¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE NURSE HAD A DIFFICULT TIME DISCONNECTING THE PATIENT LINE OF THE HOMECHOICE CASSETTE FROM THE FEMALE CONNECTOR. 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
    1380854 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H24B02038 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HOMECHOICE CASSETTE