BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ART PILLOW 8MM PUMP SEGM UNIVE

    MDR report key: 213829 · Received February 11, 1999

    Report

    Report Number
    8030665-1999-00053
    Event Type
    Malfunction
    Date Received
    February 11, 1999
    Date of Event
    February 8, 1999
    Report Date
    February 11, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT. SPOKE WITH REUSE TECHNICIAN WHO REPORTS TWO EVENTS IN WHICH A LEAK OCCURRED AT THE (POST) PUMP SEGMENT TO ADAPTER CONNECTION. THE LINES WERE ON THE 4TH AND 5TH USE AND HAD BEEN USED WITHOUT INCIDENT PRIOR TO THIS EVENT. BOTH LEAKS OCCURRED LATE IN THE PT TREATMENT (AT ABOUT THE 3RD HOUR). THE LINES WERE CHANGED AND THE TREATMENT COMPLETED WITHOUT FURTHER INCIDENT. THE PTS WERE REPORTED TO BE STABLE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. RT REPORTS THAT THERE MAY HAVE BEEN A >20CC BLOOD LOSS. DON NOT AVAILABLE AT THIS TIME TO CONFIRM THIS INFO. LEFT MESSAGE FOR DON TO RETURN CALL. BOTH LINES ARE AVAILABLE FOR EVAL. A RESPONSE LETTER AND MAILER HAVE BEEN SENT TO THE FACILITY. 2/11-SPOKE WITH DIRECTOR OF NURSING. REPORTS THAT ONE EVENT OCCURRED APPROXIMATELY 3/4 OF THE WAY THROUGH THE TREATMENT AND THE OTHER OCCURRED JUST AFTER INITIATION. REPORTS THAT THE BLOOD LOSS IN EACH OF THE EVENTS WAS APPROXIMATELY 30CC. BOTH PTS WERE STABLE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. REFERENCE PIR# 9900306. A MEDWATCH FORM HAS BEEN FILED BASED ON BLOOD LOSS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART PILLOW 8MM PUMP SEGM UNIVE BLOODLINE FOR HEMODIALYSIS FJK ERIKA DE REYNOSA NA R8K105

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other FRESENIUS 2008H DIALYSIS MACHINE,| F 80B DIALYZER.