BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3675098 · Received February 24, 2014

    Report

    Report Number
    2937457-2014-00285
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REQUESTED BUT HAVE NOT YET BEEN RECEIVED. THE DEVICE HAS NOT YET BEN RECEIVED FOR PHYSICAL EVALUATION AND A PLANT INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) PT REPORTED THAT HE HAD BEEN IN THE HOSPITAL FOR FIVE DAYS FOR PERITONITIS. ACCORDING TO HIS PR RN, HE WAS DIAGNOSES AND HOSPITALIZED ON (B)(6) 2014. HE HAD NOT EXPERIENCED ANY FLUID LEAKS DURING PD TREATMENT PRIOR TO THE EVENT, BUT HE WAS NOT COVERING HIS BEARD WITH HIS MASK WHEN HE WAS SETTING UP, HE HAD ALSO UNDERGONE A COLONOSCOPY IN (B)(6). HE WAS RELEASED FORM THE HOSPITAL ON (B)(6) 2014 AND IS FINE. ACCORDING TO THE HOSPITAL DISCHARGE SUMMARY, THE PT HAD PRESENTED TO THE ER ON (B)(6) 2014 WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. HE PRESENTED WITH DIARRHEA. HE WAS DIAGNOSED WITH ACUTE PERITONITIS AND ADMITTED. PD WAS SKIPPED AS IT WAS LATE, SO THE PT WAS GIVEN INTRAVENOUS VANCOMYCIN 1.5 GRAM, AND ZOSYN 2.25 DURING THE NIGHT. THE NEXT DAY, HE WAS SWITCHED TO AN INTRAPERITONEAL REGIMENT OF FORTAZ, TOBRA, AND VANCOMYCIN. HE AS ALSO GIVEN 40MG LOVENOX. THE ATTENDING PHYSICIAN NOTED THAT RETRAINING WAS INDICATED FOR THE PT REGARDING CONNECTING FOR PD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111713 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R LIBERTY CYCLER SET| DELFLEX