BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMC CASSETTE

    MDR report key: 7626049 · Received June 21, 2018

    Report

    Report Number
    8030665-2018-00937
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    June 4, 2018
    Report Date
    July 12, 2018
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE COMPLAINT SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER OF PRODUCT INVOLVED IS UNKNOWN. THEREFORE A SEARCH ON THE COMPLAINT MANAGEMENT SYSTEM WAS PERFORMED OF THE LOTS DELIVERED TO THE PATIENT, WITH A TIME FRAME OF THREE MONTHS BEFORE OF THE EVENT DATE FROM (B)(6) 2018 THRU (B)(6) 2018 RESULTING IN 1 LOT WITH CODE 050-87212, 1 LOT WITH CODE 050-87215 AND 2 LOTS WITH CODE 050-87216. ACCORDING TO THE COMPLAINT MANAGEMENT SYSTEM NO PRODUCT IS AVAILABLE OF THE LOTS DELIVERED TO THE PATIENT, ON DISTRIBUTION CENTERS TO BE ANALYZED. THE ENTIRE LOTS HAVE BEEN SOLD AND DISTRIBUTED; THE DEVICE HISTORY RECORDS [DHR] OF POTENTIAL RELATED LOTS WERE REVIEWED AND NO NONCONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE ASSEMBLY OF THESE LOTS WERE FOUND. THE PRODUCT INVOLVED MET SPECIFICATIONS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING FROM THE BLUE PIN ON THEIR PATIENT LINE. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 0 TREATMENT, DURING THE TECHNICAL SERVICES CALL THE PATIENTS PROGRESSED TO FILL 1 OF TREATMENT. THE CAUSE OF THE LEAK IS UNKNOWN. FLUID DID NOT COME INTO CONTACT WITH THE CYCLER. THE PATIENT WAS ADVISED TO RESET THE CYCLER WITH ALL NEW SUPPLIES. ADDITIONAL INFORMATION WAS SOLICITED, BUT UNAVAILABLE.

    Description of Event or Problem · 1

    ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469108 FMC CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. FMC CASSETTE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1