BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2671108 · Received July 17, 2012

    Report

    Report Number
    2937457-2012-00029
    Event Type
    Other
    Date Received
    July 17, 2012
    Date of Event
    June 15, 2012
    Report Date
    June 19, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN DEVICE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ON (B)(6) 2012: THE PATIENT'S PD RN CALLED TECH SUPPORT ON BEHALF OF THE PATIENT WANTING TO KNOW WHY CYCLER WAS NOT REPLACED WHEN HE CALLED ON (B)(6) 2012, ABOUT DRAINING 6112 ML DURING TREATMENT AND ALARMS RECEIVED. TREATMENT DATA FOR (B)(6) 2012: NO DAYTIME EXCHANGE; 0/ 383/12/-1117; 01 2996/49/103/6112/51/3116; 2/ 3003/21/85/2911/22/-93; 3/ 2002/25/93/4922/94/1919; 4/ 3007/13/87/3297/35/289; 5/ 1496/7. ADDITIONAL EVENT INFORMATION: (B)(6) 2012: PATIENT'S WIFE STATES THAT THE SUPPLY BAGS WERE NOT EMPTY AND CONTAINED THE PROPER VOLUME AS EXPECTED FOLLOWING THE FIRST FILL. HE DID NOT EXPERIENCE ANY PAIN AND CONTINUED HIS TREATMENT PLUS 3 ADDITIONAL TREATMENTS WITHOUT INCIDENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED DURING OR AFTER THIS EVENT AND HE CONTINUES WITH CCPD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK