BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HEMODIALYSIS SYSTEM W/BIBAG

    MDR report key: 5707390 · Received June 8, 2016

    Report

    Report Number
    2937457-2016-00600
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    May 11, 2016
    Report Date
    September 1, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K121341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. FOLLOW-UP INFORMATION WAS PROVIDED BY THE BIOMED AT THE USER FACILITY WHO REVEALED THAT THE REPORTED ISSUE WAS NOT DUPLICATED AFTER REMOVING THE UNIT FROM SERVICE AND TESTING. FUNCTIONAL TESTING PERFORMED BY THE BIOMEDICAL ENGINEER CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS NOT ABLE TO BE CONDUCTED BY THE MANUFACTURER AS THE 2008T HEMODIALYSIS (HD) MACHINE IN QUESTION WAS NOT KNOWN, THEREFORE, THE SERIAL NUMBER WAS NOT ABLE TO BE PROVIDED. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE ¿DHR REVIEW CHECKLIST & RELEASE PROCEDURE.¿ P/N 5000658; A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. THE REPORTED EVENT OF MACHINE FAILED TO ALARM FOR A BLOOD LEAK WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL FOLLOW-UP WAS PERFORMED AND THE SERIAL NUMBER FOR THE MACHINE IN QUESTION WAS OBTAINED FROM THE USER FACILITY. MANUFACTURING INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. FOLLOW-UP INFORMATION WAS PROVIDED BY THE BIOMED AT THE USER FACILITY WHO REVEALED THAT THE REPORTED ISSUE WAS NOT DUPLICATED AFTER REMOVING THE UNIT FROM SERVICE AND TESTING. FUNCTIONAL TESTING PERFORMED BY THE BIOMEDICAL ENGINEER CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE REPORTED EVENT OF MACHINE FAILED TO ALARM FOR A BLOOD LEAK WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTERNAL DIALYZER BLOOD LEAK OCCURRED SOON AFTER THE PATIENT'S HEMODIALYSIS (HD) TREATMENT WAS INITIATED. THE BLOOD LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE, HOWEVER, THE MACHINE DID NOT ALARM. REPORTEDLY, THE TREATMENT WAS ENDED BY THE STAFF MEMBER OVERSEEING THE PATIENT PRIOR TO BLOOD REACHING THE BLOOD LEAK DETECTOR. NO DIALYZER DAMAGE WAS VISIBLE. IT IS UNKNOWN IF BLOOD TEST STRIPS WERE USED. THE PATIENT'S ESTIMATED BLOOD LOSS WAS APPROXIMATELY 250ML. NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT AS A RESULT OF THIS EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER AS IT WAS DISCARDED BY THE USER FACILITY. FOLLOWING THE EVENT, THE MACHINE WAS PULLED FROM THE FLOOR FOR TESTING. FUNCTIONAL TESTING PERFORMED BY THE ONSITE BIOMEDICAL TECHNICIAN CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE MACHINE, WHICH WAS FOUND TO BE IN GOOD OPERATING CONDITION, PASSED ALL TESTING; NO REPAIRS OR CALIBRATIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360711 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008T

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR