BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN. / EXT. DL

    MDR report key: 5340401 · Received December 29, 2015

    Report

    Report Number
    8030665-2015-00612
    Event Type
    Injury
    Date Received
    December 29, 2015
    Date of Event
    December 1, 2015
    Report Date
    March 28, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKC
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. THE COMPLAINT DEVICE LOT NUMBER WAS NOT REPORTED, HOWEVER THE SALES AND SHIPPING RECORDS FOR THE PATIENT WERE REVIEWED FOR THREE MONTHS PRIOR TO THE DATE OF OCCURRENCE. NO PRODUCT WAS AVAILABLE FROM THESE LOTS IN DISTRIBUTION CENTERS TO BE ANALYZED, AS THE ENTIRETY OF THE LOTS HAVE BEEN SOLD AND DISTRIBUTED. DEVICE HISTORY REVIEW WAS PERFORMED ON THE POTENTIAL RELATED LOTS. NO NON-CONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE MANUFACTURING PROCESS WERE FOUND FOR THESE LOTS. THE PRODUCT INVOLVED MET CURRENT SPECIFICATIONS. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE SYSTEM LEVEL REVIEW OF CYCLER DEVICE AND CONCOMITANT PRODUCTS FOUND NO INDICATION THAT THE PRODUCTS CAUSED OR CONTRIBUTED IN ANY WAY TO THE CLINICAL EVENT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT INITIALLY REPORTED TROUBLE DRAINING AND A RECENT HOSPITAL DISCHARGE. DURING FOLLOW UP WITH PATIENT'S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), IT WAS LEARNED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2015 FOR NO-GROWTH PERITONITIS, PER PDRN, THE PATIENT RECEIVED A 14 DAY COURSE OF UNKNOWN ANTIBIOTICS AND IS RECOVERING. THE PDRN STATED THERE HAD BEEN NO BREAK IN ASEPTIC TECHNIQUES OR COMPROMISE OF STERILE PATHWAY PRIOR TO DIAGNOSIS OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857240 LIBERTY CYCLER SET, SINGLE CONN. / EXT. DL FKC FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R