BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMC BLOODLINE

    MDR report key: 7548589 · Received May 29, 2018

    Report

    Report Number
    8030665-2018-00796
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    June 7, 2018
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K012242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE FAILURE MODE CANNOT BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. A MANUFACTURING REVIEW WAS PERFORMED OF THE PRODUCTS SHIPPED TO THE DIALYSIS CENTER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE INDICATED THAT TWELVE LOT NUMBERS FROM PRODUCT CATALOG 03-2722-9 AND TWO LOT NUMBERS FROM PRODUCT CATALOG NUMBER 03-2794-0 WERE DELIVERED TO THE CUSTOMER. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOTS MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A USER FACILITY CLINICAL MANAGER (CM) REPORTED THAT THE CONNECTION BETWEEN THE FRESENIUS BLOODLINES AND THE BAXTER DIALYZERS DO NOT FEEL SECURE AND STATED THAT IT TAKES AN EFFORT TO ENSURE THE LINES ARE CONNECTED PROPERLY AND ARE SECURED. THE CM STATED THAT THIS ISSUE DOES NOT OCCUR WITH A FRESENIUS DIALYZER ONLY WITH THE BAXTER ONES. THE CLINICAL MANAGER STATED THAT WITHIN THE FIRST HOUR OF THE PATIENT TREATMENT HEMODIALYSIS (HD) TREATMENT, SHE TOUCHED THE CONNECTION TO SEE IF THEY¿RE SECURED AND SHE NOTICED BLOOD LEAKING FROM THE CONNECTION. THE LEAK ONLY OCCURRED WHEN SHE TOUCHED THE CONNECTION TO CHECK FOR SECURITY. THE CM STATED THAT THE PATIENT WAS ABLE TO FINISH TREATMENT ON THE SAME MACHINE WITH THE SAME SUPPLIES. SHE RE-SECURED THE CONNECTIONS BETWEEN THE BLOODLINES AND THE DIALYZER. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENT, INJURIES, OR REQUIRED MEDICAL INTERVENTION DUE TO THIS INCIDENT. THE PATIENT ESTIMATED BLOOD LOSS WAS APPROXIMATELY 10ML. THE CLINICAL MANAGER WAS NOT ABLE TO PROVIDE THE FRESENIUS BLOODLINES INFORMATION; HOWEVER STATED THAT THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391275 FMC BLOODLINE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ERIKA DE REYNOSA, S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR BAXTER DIALYZER