BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ART PILLOW 8MM PUMP SEGM UNIVE

    MDR report key: 241850 · Received September 22, 1999

    Report

    Report Number
    8030665-1999-00263
    Event Type
    Injury
    Date Received
    September 22, 1999
    Date of Event
    August 11, 1999
    Report Date
    September 7, 1999
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT FROM CLINIC. CLINIC REPORTS THAT, A FIRST USE ARTERIAL LINE WAS FOUND TO BE CRACKED IN THE PUMP SEGMENT. AIR WAS NOTICED IN THE SYSTEM AND THE EXTRACORPOREAL CIRCUIT NEEDED TO BE DISCARDED RESULTING IN AN EBL OF APPROX. 250CC. MDR FILED DUE TO BLOOD LOSS ONLY. NO ADD'L ADVERSE EFFECTS TO PT NOTED, TELEPHONED FACILITY AGAIN ON 09/09/1999 AND SPOKE TO REP WHO INDICATED THAT THE SAMPLE IS AVAILABLE AND WILL CALL BACK WITH PT INFO. NO PT INFO RECEIVED. PHONED CLINIC ON 09/21/1999 AND FOUND THAT SAMPLE HAD BEEN DISCARDED. NO PT INFO IS AVAILABLE. INDICATED THAT REPORTER WOULD RECEIVE A CALL BACK TODAY. RECEIVED FAX ON 09/22/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART PILLOW 8MM PUMP SEGM UNIVE BLOODLINE FJK ERIKA DE REYNOSA NA 9ER015

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other