BEUDAMED
    FDA Adverse Event Death Summary report: N

    D-20 DIAFILTER

    MDR report key: 2034 · Received January 5, 1993

    Report

    Report Number
    2034
    Event Type
    Death
    Date Received
    January 5, 1993
    Date of Event
    November 16, 1992
    Report Date
    December 2, 1992
    Manufacturer
    BAXTER - HEALTHCARE CORPORATION
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SAME AS ORIGINAL REPORTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Description of Event or Problem · 1

    PATIENT WAS IN CRITICAL CONDITON AND WAS MADE A "NO CODE" STATUS BY FAMILY AND PHYSICIAN. PATIENT WAS INTERMITTENTLY CONFUSED AND RESTRAINED. BETWEEN 7:45 A.M. AND 8:00 PATIENT'S PRIMARY CARE NURSE DID A FULL ASSESSMENT. PATIENT'S BLOOD PRESSURE AND RESPIRATIONS WERE NORMAL. AT 8:00 A.M. RESPIRATORY THERAPIST WAS AT PATIENT'S BEDSIDE AND NOTICED DECREASED RESPIRATIONS AND BODY FLUIDS ON THE BED. THE THERAPIST CALLED THE NURSE CALLED THE NURSE. BLOOD PRESSURE WAS DROPPING; A CODE WAS CALLED; THE PATIENT WAS PRONNOUNCED. THE NURSE SEARCHED FOR THE SOURCE OF BLOOD LOSS AND NOTED THE CAP HAD BECOME DISLODGED. THIS WAS THE LUERLOCK CAP ON THE VENOUS SIDE OF THE MACHINE WHERE THE TWO LINES CONNECT TO THE VENOUS TUBE. WE DO NOT KNOW HOW THE CAP BECAME DISLODGED. THE R.N. SAYS THE PATIENT MAY HAVE BEEN ABLE TO REACH THE PORTAL AND RELEASE ITDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-20 DIAFILTER AMICON DIAFILTER - 20 HEMOFILTER FKJ BAXTER - HEALTHCARE CORPORATION D L 0663

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death