BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYS., WITH CDX

    MDR report key: 7637190 · Received June 26, 2018

    Report

    Report Number
    2937457-2018-01790
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 7, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861100897
    PMA / PMN Number
    K093902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. A SERIAL NUMBER SEARCH IN THE PTC COMPLAINT SYSTEM FOUND COMPLAINT NUMBERS (B)(4) AND (B)(4) WITH ULTRAFILTRATION PUMP ISSUES WITHIN 90 DAYS OF THE NOTIFIED DATE. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: PMA/510(K) # CORRECTED TO K093902.

    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 BIOMED TECHNICIAN REPORTED A 2008T MACHINE'S UF PUMP DID NOT START AFTER UNPAUSING THE TREATMENT. THE CUSTOMER EXPLAINED THAT THE PUMP WAS NEVER TURNED BACK ON WHEN TREATMENT WAS CONTINUED AFTER THE PAUSE. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON THE SAME MACHINE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE ANY ADDITIONAL TREATMENTS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480371 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 2008T N/A 00840861100897

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS BLOODLINES| FRESENIUS BLOODLINES