BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXELTRA PLUS 210 DIALYZER

    MDR report key: 634611 · Received September 9, 2005

    Report

    Report Number
    1423500-2005-01423
    Event Type
    Injury
    Date Received
    September 9, 2005
    Date of Event
    August 10, 2005
    Report Date
    August 11, 2005
    Manufacturer
    NIPRO CORP
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2005 THE CUSTOMER REPORTED AN INCIDENT WHERE THE PT HAS BEEN DIAGNOSED WITH HEMOLYSIS AFTER USING AN EXCELTRA 210 DIALYZER ON A COBE C3 HEMODIALYSIS MACHINE. GAMBRO BLOODLINES, AND MEDISYSTEMS SINGLE FISTULA NEEDLE WITH MASGERGARD DISTRIBUTED BY BAXTER. THERE WERE NO ALARMS NOTICED DURING THE TREATMENT. THE FACILITY DOES NOT REUSE DIALYZERS. THE TREATMENT STARTED AT 05:14. THIRTY MINUTES PRIOR TO THE END OF THE TREATMENT THE PT COMPLAINED OF NAUSEA AND STOMACH CRAMPS. AT 8:37 THE BLOOD PRESSURE HAD INCREASED FROM 106/73 TO 163/107 AND THE PULSE INCREASED TO 103 AT 8:28 AND WAS 93 AT 8:37. TREATMENT WAS DISCONTINUED AT 08:47. THE END OF TREATMENT BLOOD PRESSURE WAS 182/128. THE TREATMENT ENDED 12 MINUTES EARLY. THE DIALYZER WAS CLOTTED AT THE TIME OF RINSE BACK; BLOOD WAS ABLE TO BE RETURNED TO THE PT. THE NURSING STAFF STATED THAT THE PT HAD COMPLAINED OF ABDOMINAL PAIN BUT THAT WAS SOMEWHAT NORMAL FOR THIS PT. THE PT'S BLOOD PRESSURE AND PULSE REMAINED STABLE UNTIL 20 MINUTES BEFORE THE END OF TREATMENT. AT 8:28 THE BLOOD PRESSURE HAD DROPPED FROM 120/77 TO 106/73. THE PT WAS GIVEN 100CC OF NORMAL SALINE AND THE UF RATE WAS REDUCED TO 0.2. THE PT WAS LATER ADMITTED TO THE HOSP. THE DATE AND TIME OF ADMISSION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELTRA PLUS 210 DIALYZER HOLLOW FIBER DIALYZER FJI NIPRO CORP EXCELTRA 210 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention