BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2141123 · Received June 22, 2011

    Report

    Report Number
    8030665-2011-00031
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    April 28, 2011
    Report Date
    June 22, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    AN INITIAL REPORT RECEIVED FROM A PERITONEAL DIALYSIS NURSE STATED THAT HER PT HAD NOTICED A CASSETTE LEAK AND "SHORTLY AFTER", THE PT DEVELOPED PERITONITIS. ADD'L INFO RECEIVED ON (B)(6), 2011 STATED THAT ON (B)(6), 2011, THE PT EXPERIENCED SYMPTOMS OF PAIN, NAUSEA AND VOMITING AND WAS EVALUATED AT THE ER AND SUBSEQUENTLY TREATED FOR PERITONITIS. FROM MEDICAL RECORDS RECEIVED, THE COURSE OF TREATMENT RAN FROM (B)(6), 2011 THRU (B)(6), 2011 AS THE INFECTION WAS DIFFICULT TO CLEAR. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN INFO IN ORDER TO CORRELATE THE DATES BETWEEN THE REPORTED DEVICE LEAK AND THE DEVELOPMENT OF PERITONITIS. THE PT REPORTED THE FOLLOWING STATEMENT "DEFINITELY NOT WITHIN 2 DAYS. IF COULD HAVE BEEN UP TO A WEEK". CURRENTLY, THE PT IS FINE AND CONTINUES TO RECEIVE TREATMENT AS ORDERED. THERE IS NO SAMPLE AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R LIBERTY CYCLER