BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 8

    MDR report key: 114778 · Received August 6, 1997

    Report

    Report Number
    114778
    Event Type
    Injury
    Date Received
    August 6, 1997
    Date of Event
    April 14, 1997
    Report Date
    April 18, 1997
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED AT FACILITY WITHOUT COMPLAINTS. TREATMENT INITIATED VIA RT JUGULAR LINE WITHOUT INCIDENT AT 1220. AT 1400, MACHINE TEMPERATURE ALARM TRIGGERED. CARE GIVERS AND MEDICAL PERSONEL NOTED SLOW DRIPPING OF BLOOD FROM THE VENOUS END OF DIALYZER HEADER. HEADER CAP WAS TIGHTENED. LEAKAGE CEASED. PT'S BP AT 1515 70/92 AND NORMAL SALINE GIVEN. TREATMENT TERMINATED PER PHYSICIAN REQUEST. EBL APPROX. 700 CC. ALBUMIN ADMINISTERED TO PT. PT. VOMITED. BP INCREASED TO 180/54. PT. TAKEN TO HOSP VIA AMBULANCE. PT. RECEIVED FOUR UNITS BLOOD DURING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS 8 DIALYZER KDI FRESENIUS FRESENEIUS 8 6J01008

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| O| R NMC ARTERIAL LINE W/PILLA 003-9608-5| NMC VENOUS LINE 03-7303-5