BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 3032596 · Received April 1, 2013

    Report

    Report Number
    2937457-2013-00041
    Event Type
    Other
    Date Received
    April 1, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 3, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS AVAILABLE AT THIS TIME AS PT'S CHART IS AT ANOTHER CLINIC. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    PT CALLED TECHNICAL SERVICES WITH OPERATIONAL QUESTION; PT WAS NOT ON TREATMENT WHEN CALLED. PT WOULD LIKE TO KNOW WHAT COULD CAUSE HER TO HAVE TROUBLES ON HER TREATMENT LAST NIGHT. PT STATED THAT CYCLER WAS NOT SWITCHING ON PT'S DRAIN CYCLES AND IT BECAME PAINFUL (DRAIN 3). PT HAD TO MANUALLY BYPASS SO CYCLER COULD CONTINUE WITH FILL. PT STATED THAT THE PREVIOUS WEDNESDAY, HER IQ CARD WAS FORMATTED AND SINCE THEN PT IS HAVING PROBLEMS. THE RECORDS FOR LAST NIGHT, (B)(6) 2003 WERE: DRAIN 0: DRAIN VOLUME 2,415 ML IN 31 MINUTES; UF 414 ML. FILL 1: FILL VOLUME 2,012 DRAIN 2,166 ML; UF 154 ML. FILL 2: FILL VOLUME 2,012 DRAIN 2,063 ML; UF 51 ML. FILL 3: FILL VOLUME 2,012 ML DRAIN VOLUME 3,951; UF 1,939 ML. FILL 4: FILL VOLUME 2,012 ML DRAIN VOLUME 1,729; UF -283 ML. FILL 5: FILL VOLUME 2,012 ML DRAIN VOLUME 2,222 ML; UF 212 ML. FILL 6: FILL VOLUME 1,502 ML (LAST FILL). INFORMATION OBTAINED: POST MARKET CLINICAL SPECIALIST CONTACTED THE DIALYSIS CLINIC AND SPOKE WITH PERITONEAL DIALYSIS (PD) NURSE WHO STATED THAT THE PT WAS HAVING DRAIN ISSUES DUE TO AN INFECTION IN PT'S PD CATHETER. THE PT DID NOT HAVE PERITONITIS BUT HAD BIOFILM GROWTH IN THE CATHETER WHICH WAS SUBSEQUENTLY REMOVED. NO MEDICAL RECORDS ARE CURRENTLY AVAILABLE AS PT'S CHART IS AT ANOTHER CLINIC. THE PD NURSE STATED THAT THEY WERE NOT AWARE OF ANY ISSUES WITH THE CYCLER OR OTHER PRODUCTS THAT CAUSED THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132330 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 PD SOLUTION| LIBERTY CYCLER SET