BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYSIS DELIVERY SSYTEM

    MDR report key: 3010249 · Received March 12, 2013

    Report

    Report Number
    2937457-2013-00018
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    September 25, 2012
    Report Date
    September 28, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NOT REPORTED OR SUSPECTED DEVICE MALFUNCTION DURING THE TREATMENT. THE DEVICE WAS EVALUATED BY THE FACILITY BIOMED ON (B)(6) 2012 AND THE FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) ON (B)(6) 2012. THE UF VARIANCE REPORTED BY THE RES OF 24.4ML PER 24 STROKES COULD RESULT IN A UF VARIANCE OF APPROXIMATELY 110 ML WITH THE SET UF GOAL OF 6.5KG. THE 110ML EXCESS FLUID REMOVED IN AN ADULT IS MINIMAL AND IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED ADVERSE EVENT. A MEDICAL REVIEW OF THE INFORMATION PROVIDED IN THE TREATMENT SHEETS REVEAL AN ULTRAFILTRATION VOLUME CONSISTENT WITH HIS PRESCRIPTION FOR ULTRAFILTRATION. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORAMNCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PRE-HEMODIALYSIS TREATMENT ON (B)(6) 2012 - PT'S BLOOD PRESSURE (BP) 124/74, HEART RATE (HR) 96R; RESPIRATION 16; TEMPERATURE 96.6; WEIGHT (B)(6); FLUID OVERLOAD 7.7KG ABOVE DRY WEIGHT), PT HAD COMPLAINTS OF SHORTNESS OF BREATH; PT NEPHROLOGIST WAS NOTIFIED WITH ORDER TO INCREASE THE TREATMENT TIME BY 1HOUR. AT 10:11 TREATMENT INITIATED: BP 115/66; HR 88. ULTRAFILTRATION GOAL 6.5KG. AT 12:35 BP 141/72, HR 69, FLUID REMOVED 3.76 LITERS. STAFF REPORTS PT WAS RESTING COMFORTABLY. AT 12:45 PT COMPLAINED OF WEAKNESS; FEELING BAD; SHORT OF BREATH; BECAME UNRESPONSIVE; CPR INITIATED: CHEST COMPRESSION AND AMBU BAG WITH OXYGEN AT 6 LITERS GIVEN; 1.5 LITERS NORMAL SALINE GIVEN; AED ADVISED NO SHOCK. AT 13:15 TRANSPORTED TO EMERGENCY ROOM VIA AMBULANCE; BP 187/100; HR 94; PT HAD SPONTANEOUS RESPIRATIONS. THERE WAS NO REPORTED DEVICE MALFUNCTION DURING THE TREATMENT. PT WAS EVALUATED AT THE EMERGENCY ROOM AND EMERGENCY ROOM NOTES INDICATED THAT THE DIALYSIS STAFF WERE UNABLE TO PALPATE A PULSE AND 5 MINUTES OF CPR WAS PERFORMED. UPON ARRIVAL TO THE EMERGENCY ROOM PT HAD PULSE, WAS AWAKE AND ALERT. PT WAS TREATED FOR HYPOTENSION AND PLEURAL EFFUSION. PT HAS SINCE RETURNED TO THE DIALYSIS UNIT AND RESUMED IN-CENTER HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104585 FRESENIUS DIALYSIS DELIVERY SSYTEM HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| R| S FRESENIUS OPTIFLUX (B)(4) DIALYZER| SALINE| BLOOD LINES| BICRABONATE| ACID CONCENTRATE