BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 3010266 · Received March 12, 2013

    Report

    Report Number
    2937457-2013-00022
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 12, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMODIALYSIS MACHINE INVESTIGATION CONDUCTED BY THE FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) ON (B)(4) 2012 DETERMINED THAT THE UF PUMP STROKE VOLUME WAS OUT OF CALIBRATION AT 1.021 ML/STROKE. THE MINIMAL UF PUMP STROKE VOLUME VARIANCE OF 0.21 ML/STROKE COULD RESULT IN A UF REMOVAL OF 2.1% HIGHER THAN EXPECTED AND IS CONSIDERED INSIGNIFICANT. EXAMPLE: 63 ML IN EXCESS FOR A UF GOAL OF 3,000 ML. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRM THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE PT'S HEMODIALYSIS TREATMENT WAS INITIATED W/O INCIDENT. THE PT'S B/P WAS 210/96 AND PULSE 73 WITH A ULTRAFILTRATION (UF) GOAL SET TO REMOVE 3.9 KG. THERE WERE NO ALARMS OR PROBLEMS NOTED DURING THE TREATMENT. APPROX 2 HRS INTO THE TREATMENT, THE PT BEGAN TO COMPLAIN OF CRAMPING. THE UF WAS TURNED OFF FOR APPROX 1 HR WHEN IT WAS DISCOVERED THE PT HAD DECREASED BREATHING AND NO PULSE. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PT HAS BEEN RELEASE AND HAS RESUMED REGULARLY SCHEDULED OUTPATIENT DIALYSIS TREATMENTS. ADDITIONALLY, THE MEDICAL DIRECTOR AND RN REPORTED THEY DO NOT BELIEVE THAT THE HEMODIALYSIS MACHINE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PT RECOVERED AND RESUMED REGULARLY SCHEDULED OUTPATIENT DIALYSIS TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104329 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| O| R F160NR DIALYZER| BICARBONATE| BLOODLINES| SALINE| 45X ACID CONCENTRATE