BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F70 HEMOFLOW DIALYZER12/CS

    MDR report key: 174782 · Received June 26, 1998

    Report

    Report Number
    1713747-1998-00808
    Event Type
    Injury
    Date Received
    June 26, 1998
    Date of Event
    May 23, 1998
    Report Date
    May 29, 1998
    Manufacturer
    FRESENIUS
    Product Code
    FJI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    7/16/1998-THE COMPLAINT SAMPLE OR AN UNUSED LOT SAMPLE WAS NOT AVAILABLE FOR CO'S EVALUATION. A SAMPLE WAS RECEIVED FROM THIS NOT NUMBER FOR THE INVESTIGATION OF ANOTHER REPORTED PROBLEM (PIR# 98001173). THAT EVALUATION CONFIRMED A DELAMINATION CAUSED A HEADER CAP LEAK. CO CAN NOT CONCLUDE THAT A DELAMINATION ALSO CAUSED THIS REPORTED "BLOOD LEAK" BY THE CUSTOMER. AN ENGINEERING PROJECT HAS BEEN INITIATED TO INVESTIGATE THE CAUSE OF THE DELAMINATION AND DETERMINE APPROPRIATE CORRECTIVE ACTION. THIS COMPLAINT IS NOT CONFIRMED. CO IS CONTINUING TO MONITOR INCOMING COMPLAINTS. NO FURTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED. FOLLOW UP LETTER TO CUSTOMER SENT. COMPLAINT CLOSED. (REFERENCE PIR# 9801087).

    Description of Event or Problem · 1

    INFORMED OF COMPLAINT BY SALES MANAGER. CUSTOMER REPORTED "BLOOD LEAKS" WITH THIS PRODUCT ON 5/29/1998. TELEPHONE MESSAGES LEFT ON 5/29/1998, 6/1/1998, 6/2/1998 AND 6/3/1998. INFO VERIFIED 5/29/1998 WITH EQUIPMENT TECH. ALSO SPOKE WITH HEALTHCARE PROFESSIONAL. THERE HAVE BEEN TWO DOCUMENTED "BLOOD LEAK" EVENTS. THIS COMPLAINT IS REPORTED OF SECOND EVENT. REPORTEDLY, BLOOD WAS SENSED AND CONFIRMED IN DIALYSATE OF C3 MACHINE(BLOOD LEAK ALARM). TREATMENT WAS STOPPED, PT WAS NOT RINSED BACK(-200 ML ESTIMATED BLOOD LOSS, AND NEW DIALYZER AND TUBING SET WAS PREPARED. TREATMENT WAS RESTARTED AND COMPLETED WITHOUT FURTHER INCIDENT. HEMATOCRIT REPORTED STABLE. NO ADVERSE EFFECTS TO PT; NO MEDICAL INVERVENTION REQUIRED. ACTUAL DIALYZER WAS DISCARDED. HAVE REQUESTED COMPANION SAMPLE IF AVAILABLE FOR EVAL. 6/17/1998 INFORMED BY TECH THAT THERE ARE NO COMPANION LOT SAMPLES AVAILABLE FOR EVAL, HOWEVER COMPLAINT SAMPLE FROM THIS LOT (PIR# 9801173) WILL BE SENT FOR EVAL OF ANOTHER COMPLAINT. MDR FILED BASED ON VOLUME OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F70 HEMOFLOW DIALYZER12/CS HIGH FLUX DIALYZER FJI FRESENIUS F70NR 7J05508

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other COBE C3 DIALYSIS MACHINE, HEMODIALYSIS 3X WEEK