BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F80B (HF/PS/1.8/H)

    MDR report key: 168810 · Received May 19, 1998

    Report

    Report Number
    1713747-1998-00777
    Event Type
    Injury
    Date Received
    May 19, 1998
    Date of Event
    April 29, 1998
    Report Date
    May 5, 1998
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PIR #9800898 SAMPLE WAS RETURNED FOR EVALUATION. CO IS UNABLE TO CONFIRM THE REPORTED COMPLAINT OF INTERNAL "BLOOD LEAK" WITHOUT A SAMPLE FOR EVALUATION. TRENDING AT THE MFG SITE SHOWED NO SIGNIFICANT TREND. AND SINCE THE FAILURE WAS DETECTED DURING THE 18TH USE OF THE DEVICE, OTHER CONTRIBUTING FACTORS SUCH AS REPROCESSING AND HANDLING WERE PRESENT. THE LEAK WAS FOUND IMMEDIATELY AND RESPONDED TO WITHOUT ADVERSE EFFECTS TO THE PT. CUSTOMER FOLLOW-UP SENT. COMPLAINT CLOSED.

    Description of Event or Problem · 1

    RECEIVED NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM FACILITY'S CLINICAL VARIANCE REPORT, FAXED TO QUALITY SYSTEMS BY THE CHARGE NURSE. SPOKE WITH DIRECTOR OF NURSING (CHARGE NURSE ON VACATION) WHO REPORTED A BLOOD LEAK ON THIS 18TH USE DIALYZER. AS TREATMENT WAS INITIATED, BLOOD VISIBLE IN DIALYSATE OUTFLOW. TREATMENT IMMEDIATELY DISCONTINUED. ESTIMATED BLOOD LOSS FOR THIS PT APPROX. 200 CC DUE TO LOSS OF EXTRACORPOREAL SYSTEM. DIR. OF NURSING REPORTS THAT THE PT WAS STABLE THROUGHOUT THE EVENT, NO TRANSFUSION OR OTHER INTERVENTION REQUIRED. THE DIALYZER HAS BEEN SAVED AND IS AVAILABLE FOR EVALUATION. A RESPONSE LETTER AND MAILER HAS BEEN SENT TO THE FACILITY. MEDWATCH FILED BASED ON BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F80B (HF/PS/1.8/H) DIALYZER FOR HEMODIALYSIS KDI FRESENIUS F80B 7J00208

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other DIALYSIS 3 TIMES/WEEK.| LINE 7303, DIALYSIS 3X/WEEK.| FRESENIUS H MACHINE, ARTERIAL LINE 7608, VENOUS