BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4091632 · Received August 22, 2014

    Report

    Report Number
    2937457-2014-02271
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REVIEWED MEDICAL RECORDS AND THE CLINICAL INVESTIGATION REVEALS THE FOLLOWING. BASED ON THE 22 PAGES OF MEDICAL RECORDS INFO AND A REVIEW OF THE DOCUMENTATION IN THE COMPLAINT INFO SYSTEM. IT APPEARS THAT ON (B)(6) /2014, THE PT WAS DIAGNOSED WITH STAPHYLOCOCCUS EPIDERMIDIS PERITONITIS. THIS IS THE PT'S 2 D EPISODE OF STAPH PERITONITIS WITHIN 6 WEEKS. THE PT WAS HOSPITALIZED FOR STAPH PERITONITIS FROM (B)(6) 2014 AND WAS TREATED WITH VANCOMYCIN AS AN OUTPATIENT FOLLOWING HER DISCHARGE.. THE PT HAS A HISTORY OF NONCOMPLIANCE WITH HER PERITONEAL DIALYSIS TREATMENTS AND IS BLIND. HER MOTHER PERFORMS THE TREATMENTS FOR HER AND DUE TO THE PT'S NONCOMPLIANCE SHE RECEIVES PERITONEAL DIALYSIS 5 TIMES PER WEEK. THE PT'S PD RN STATED THAT SHE BELIEVED THE PERITONITIS WAS A RESULT OF POOR ASEPTIC TECHNIQUE. THE PT AND HER MOTHER WILL RECEIVE RE-TRAINING FOR PROPER ASEPTIC TECHNIQUE WHITE PERFORMING PD AFTER THE FIRST EPISODE OF PERITONITIS. PERITONITIS IS A KNOWN COMPLICATION OF PERITONEAL DIALYSIS, USUALLY CAUSED BY A BREAK IN ASEPTIC TECHNIQUE. IT IS UNDETERMINED IF THERE IS A REASONABLE SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE PERITONITIS EVENT. THE PLANT INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) CALLED TECHNICAL SUPPORT FOR THE PT'S CYCLER REPLACEMENT HISTORY. AT THAT TIME, THE NURSE REPORTED THE PT HAD 2 EPISODES OF PERITONITIS "IN THE PAST 6 WEEKS" AND THE NURSE WANTED TO KNOW HOW MANY CYCLER REPLACEMENTS SHE HAD RECEIVED. ACCORDING TO THE PD RN, SHE SUSPECTS THE PERITONITIS WAS DUE TO A BREACH IN ASEPTIC TECHNIQUE. ACCORDING TO MEDICAL RECORDS RECEIVED, THE PT WHO IS LEGALLY BLIND, WAS SEEN IN HER MONTHLY PERITONEAL DIALYSIS (PD) CLINIC VISIT ON (B)(6) 2014. THE RECORD INDICATES THE PT'S EFFLUENT WAS "HAZY". A PD EFFLUENT CULTURE WAS OBTAINED AND THE PT WAS STARTED TO ANTIBIOTICS IPF (INTRA-PERITONEAL). THE ORGANISM IDENTIFIED FROM THE CULTURE WAS STAPH EPIDERMITIS. THIS IS THE SECOND PERITONITIS DIAGNOSIS IN THE PAST 6 WEEKS. THERE WERE NO LEAKS DURING TREATMENT REPORTED OR ALLEGED AND A SEARCH OF THE COMPLAINT INFO SYSTEM CONFIRMS THIS. THE PT WAS NOT HOSPITALIZED AND CONTINUES ON CCPD. EFFLUENT IS NOW CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508084 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention ROCALTROL| LIBERTY CYCLER SET| FRESENIUS PD SOLUTION| VITAMIN D2| RENVELA