BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F4 DIALYZER PRODUCTION ASSY.

    MDR report key: 6109322 · Received November 17, 2016

    Report

    Report Number
    1713747-2016-00555
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 25, 2016
    Report Date
    January 6, 2017
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K874872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED AT THE COMPLETION OF THIS ACTIVITY.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION, AND THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. A LOT HISTORY REVIEW WAS PERFORMED OF THE PRODUCTS SHIPPED TO THE DIALYSIS CENTER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. NO INFORMATION WAS FOUND AND NO LOTS WERE IDENTIFIED DURING THIS REVIEW, WHICH SOUGHT TO IDENTIFY THE LOT NUMBERS FOR ALL FRESENIUS DIALYZERS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. A SECONDARY SEARCH WAS PERFORMED TO IDENTIFY THOSE DIALYZER PRODUCTS, MOST RECENTLY DELIVERED TO THE USER FACILITY, WITH THE NOTED CATALOG NUMBER (0500318E). NO FRESENIUS DIALYZERS, WHICH MET THE SEARCH CRITERIA, WERE FOUND TO HAVE BEEN DELIVERED TO THIS ACCOUNT WITHIN THE LAST THREE YEARS. AS THE LOT NUMBER WAS NOT IDENTIFIED BY THE USER FACILITY AND SINCE NO LOT INFORMATION WAS IDENTIFIED DURING THE SHIP HISTORY, A MANUFACTURING REVIEW WAS NOT ABLE TO BE PERFORMED. THEREFORE, NO PRODUCTION RECORDS WERE ABLE TO BE REVIEWED FOR PRODUCT NON-ACCEPTANCE OR DEVIATION IN THE MANUFACTURING PROCESS AS IT RELATED TO THE COMPLAINT EVENT. THE HEMOFLOW F4 HOLLOW FIBER DIALYZER PRODUCTS INSTRUCTIONS FOR USE (IFU) DOCUMENT NOTES THE FOLLOWING UNDER "ANTICOAGULATION" WITHIN THE GENERAL INFORMATION SECTION. "UNLESS MEDICALLY CONTRAINDICATED, IT IS RECOMMENDED TO ANTICOAGULATE THE EXTRACORPOREAL CIRCUIT DURING HEMODIALYSIS. THE CHOICE OF ANTICOAGULANT, THE DOSE, AND METHOD OF ADMINISTRATION IS THE DECISION OF THE PHYSICIAN.¿ THE INSERT SHEET FURTHER DETAILS THE PRODUCT INDICATION NOTING ¿F3, F4 DIALYZERS ARE DESIGNED FOR SINGLE USE IN ACUTE AND CHRONIC HEMODIALYSIS.¿

    Description of Event or Problem · 1

    A HEMODIALYSIS REGISTERED NURSE (HDRN) AT THE USER FACILITY REPORTED A BLOOD LOSS EVENT THAT OCCURRED DURING A PATIENT TREATMENT. THE HDRN STATED THAT THE PATIENT WAS UNDERGOING SUSTAINED LOW EFFICIENCY DIALYSIS (SLED) WHEN THE HD MACHINE GENERATED AN ALARM. THE ALARM TYPE WAS NOT REPORTED. ACCORDING TO THE HDRN, THE SLED TREATMENT WAS BEING MONITORED BY AN INTENSIVE CARE UNIT (ICU) RN. THE ICU RN STATED THAT THE MACHINE ALARM OCCURRED WHILE THE PATIENT WAS BEING MOVED, AND THE BLOOD PUMP STOPPED AS DESIGNED. HOWEVER, THE ICU RN WAS NOT ABLE TO CONFIRM HOW LONG THE PUMP HAD BEEN STOPPED. AFTER RE-SETTING THE ALARM, THE DIALYZER APPEARED TO BE CLOTTED, SO THE TREATMENT WAS NOT ABLE TO BE RE-STARTED. THE PATIENT WAS RE-SETUP ON A NEW SYSTEM, AND THEN THE TREATMENT WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 150ML. IT IS NOT KNOWN IF THE PATIENT WAS RECEIVING HEPARIN FOR SYSTEM PATENCY AT THE TIME OF THE EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    A HEMODIALYSIS REGISTERED NURSE (HDRN) AT THE USER FACILITY REPORTED A BLOOD LOSS EVENT THAT OCCURRED DURING A PATIENT TREATMENT. THE HDRN STATED THAT THE PATIENT WAS UNDERGOING SUSTAINED LOW EFFICIENCY DIALYSIS (SLED) WHEN THE HD MACHINE GENERATED AN ALARM. THE ALARM TYPE WAS NOT REPORTED. ACCORDING TO THE HDRN, THE SLED TREATMENT WAS BEING MONITORED BY AN INTENSIVE CARE UNIT (ICU) RN. THE ICU RN STATED THAT THE MACHINE ALARM OCCURRED WHILE THE PATIENT WAS BEING MOVED, AND THE BLOOD PUMP STOPPED AS DESIGNED. HOWEVER, THE ICU RN WAS NOT ABLE TO CONFIRM HOW LONG THE PUMP HAD BEEN STOPPED. AFTER RE-SETTING THE ALARM, THE DIALYZER APPEARED TO BE CLOTTED, SO THE TREATMENT WAS NOT ABLE TO BE RE-STARTED. THE PATIENT WAS RE-SETUP ON A NEW SYSTEM, AND THEN THE TREATMENT WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 150ML. IT IS NOT KNOWN IF THE PATIENT WAS RECEIVING HEPARIN FOR SYSTEM PATENCY AT THE TIME OF THE EVENT. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE COMPLAINT DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759866 F4 DIALYZER PRODUCTION ASSY. DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1