BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 144666 · Received January 16, 1998

    Report

    Report Number
    8030665-1997-00598
    Event Type
    Death
    Date Received
    January 16, 1998
    Date of Event
    December 15, 1997
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    INITIALLY RECEIVED INFO REGARDING COMPLAINT FROM MEDWATCH FORM FILED BY FACILITY. DIRECTOR OF NURSING REPORTS THAT ON 12/15 THE TREATMENT WAS INITIATED WITHOUT INCIDENT FOR THIS CHRONIC HEMO PT. PT WAS REPORTEDLY CHECKED AFTER 45 MINUTES, B/P NORMAL, NOTHING UNUSUAL NOTED. APPROX 15 MINUTES LATER, THE PT WAS FOUND TO BE UNRESPONSIVE. THE VENOUS LINE HAD BECOME DISCONNECTED FROM THE RIGHT SUBCLAVIAN PERMACATH, THE DON STATES THAT THE CHARGE NURSE REPORTED TO HER THAT THERE WAS AN EBL OF MORE THAN 100CC BUT FELT THAT THE AMOUNT OF BLOOD ON THE FLOOR "WAS NOT REALLY A SIGNIFICANT AMOUNT". BLOOD PRESSURE INITIALLY NORMAL BUT WITH A HEART RATE OF 192. ALLEGEDLY, THE PT THEN BECAME HYPOTENSIVE AND RESPIRATORY ARRESTED. PT WAS THEN RESUSCITATED AND TRANSPORTED TO THE HOSP VIA AMBULANCE. HCT 36.3 HGB 11.0 ON 12/10. UPON ADMISSION TO ER, HGB 11.6. DIAGNOSIS REPORTED AS "STROKE". PT REMAINED UNRESPONSIVE, BRAIN DEATH WAS DETERMINED AND THE PT WAS DISCONTINUED FROM LIFE SUPPORT ON 12/17 AND EXPIRED ON THIS DAY. ACTUAL SAMPLES WERE DISCARDED ON THE DAY OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death R SUBCLAV PERMCATH, TERUMO DIALYZER