BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSTOM COMBI SET

    MDR report key: 2023155 · Received February 15, 2011

    Report

    Report Number
    8030665-2011-00008
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 15, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THE FOLLOWING EVENT: A VENOUS LINE SEPARATED AT THE LUER LOCK CONNECTOR RESULTING IN A BLOOD LOSS OF 400-500 ML. THE FACILITY WAS CONTACTED FOR ADD'L INFO REGARDING THIS INCIDENT. THE PT HAD BEEN UNDERGOING DIALYSIS VIA AN ARTERIO-VENOUS FISTULA WHEN AT 2 1/2 HRS INTO THE TREATMENT, THE MAINLINE VENOUS TUBING SEPARATED FROM THE VENOUS LUER LOCK. THE MACHINE ALARMED AND ALERTED OF THE EVENT. THE RPTR STATED THAT THE BLOOD PUMP STOPPED. THE ESTIMATED BLOOD LOSS WAS REPORTED AS 400-500 ML AND WAS DESCRIBED AS CONSIDERABLE. THE PT ARRESTED IN THE UNIT AND WAS RESUSCITATED, TRANSPORTED TO THE HOSPITAL AND ADMITTED TO THE ICU. IN THE HOSPITAL, THE PT WAS TRANSFUSED AND WAS REPORTED TO BE AWAKE AND ALERT. HE REMAINED IN THE ICU UNTIL HE WAS DISCHARGED TO THE NURSING HOME ON (B)(6) 2011. AT THIS TIME, NO FURTHER INFO IS AVAILABLE. IT WAS ALSO REPORTED THIS PT HAS AN EXTENSIVE MEDICAL HISTORY. IT WAS LEARNED THAT THIS PT HAD DIED SUDDENLY IN THE NURSING HOME. THE DATE OF DEATH WAS (B)(6) 2011. THERE IS NO FURTHER INFO AVAILABLE AND THE CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 10PR01084

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| L| O| R