BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 5213411 · Received November 5, 2015

    Report

    Report Number
    8030665-2015-00505
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    October 6, 2015
    Report Date
    March 4, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REVIEW: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE PRODUCT USED IN THE REPORTED EVENT. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE RECORD REVIEW FOUND 2 LOT NUMBER SHIPPED TO THE CUSTOMER DURING THAT TIME PERIOD. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE BATCH RECORDS CONFIRMED THAT RELEASED PRODUCT MET SPECIFICATIONS; AND DOCUMENTED MANUFACTURING PROCESS CONTROLS WERE WITHIN SPECIFICATION. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS PRODUCT CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT. THE PAPER MDR SUBMISSION (MFR REPORT # 8030665-2015-00505) FOLLOW-UP # 001 WAS SUBMITTED ON 11/FEB/2016 TO THE OFFICE OF CENTER FOR DEVICES AND RADIOLOGICAL HEALTH AND RETURNED TO FRESENIUS MEDICAL CARE WITH A COVER LETTER DATED 17/FEB/2016 STATING THE PAPER MDR SUBMISSION WAS NOT ACCEPTED. THEREFORE, THE REPORT WAS RESUBMITTED ELECTRONICALLY VIA WEBTRADER.

    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. THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE INCIDENTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT PRESENTED TO INPATIENT DIALYSIS WITH A PRE-EXISTING HISTORY OF CARDIAC ISSUES AND EXPERIENCED CARDIAC ARREST. WHILE IN TREATMENT THE PATIENT CODED AND HIS INTERNAL DEFIBRILLATOR FIRED UNSUCCESSFULLY. A CRASH CART WAS DEPLOYED AND THE HOSPITAL DEFIBRILLATOR WAS SUCCESSFUL IN RESTORING THE PATIENT'S CARDIAC RHYTHM. THE PATIENT WAS DEFIBRILLATED DUE TO A PREVIOUS HEART CONDITION. THE PATIENT HAD BEEN PLACED ON DNR. THE PATIENT HAD A 10% EJECTION FRACTION RATE AND ONGOING HEART ISSUES. THE PATIENT EXPERIENCED MULTIPLE ACUTE MI'S (MYOCARDIAL INFARCTION) DURING THE HOSPITALIZATION. ON (B)(6) 2015 THE PATIENT EXPIRED DURING TREATMENT ON ANOTHER CYCLER. THE PDRN STATED THE DOCTOR DID NOT BELIEVE THE CYCLER CAUSED THE PATIENT'S HOSPITALIZATION OR SUBSEQUENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735591 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX FRESENIUS MEDICAL CARE NORTH AMERICA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R