BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET ACCESS FLOW REVERSE CON TWISTER

    MDR report key: 22141428 · Received June 4, 2025

    Report

    Report Number
    0008030665-2025-01261
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    KOC
    UDI-DI
    00840861100316
    PMA / PMN Number
    K022536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE MANUFACTURING FACILITY RECEIVED A PRODUCT COMPLAINT SAMPLE OPEN WITH DIFFERENT PACKAGE IDENTIFIED WITH CODE NUMBER 03-2794-0 AND AN UNKNOWN LOT NUMBER. THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED. AS THE PRODUCT COMPLAINT SAMPLE WAS BEING DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS FOUND DUE TO A FRACTURE IN THE TWISTER ASSEMBLED TO THE MAIN VENOUS LINE. THIS FRACTURE WAS FOUND DURING THE HANDLING OF THE SAMPLE WHEN PERFORMING THE DISINFECTION. THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED. DURING THE INSPECTION UNDER A MICROSCOPE IT WAS FOUND THAT THE VENOUS TWISTER PORT WAS BROKEN DURING THE HANDLING WHEN PERFORMING THE DISINFECTION. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE FOUND. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS COMBISET BLOODLINES SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. UPON COMPLETION OF THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE LEAKED FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DUE TO FAULTY TWIST LINES THAT HAD NOT YET BEEN SWITCHED FOR ACCESS TESTING. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS, CHANGES IN PRESSURE AND NO DAMAGE WAS SEEN ON THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS BLOODLINE LEAKED FIFTEEN MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DUE TO FAULTY TWIST LINES THAT HAD NOT YET BEEN SWITCHED FOR ACCESS TESTING. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO LOOSE CONNECTIONS, CHANGES IN PRESSURE AND NO DAMAGE WAS SEEN ON THE BLOODLINE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672726 COMBISET ACCESS FLOW REVERSE CON TWISTER ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS KOC ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN 00840861100316

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male FRESENIUS DIALYZER.| FRESENIUS DIALYZER.| FRESENIUS HEMODIALYSIS MACHINE.| FRESENIUS HEMODIALYSIS MACHINE.