BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT GAMMA DIALYZER (CT190G)

    MDR report key: 2982209 · Received June 4, 2007

    Report

    Report Number
    1423500-2007-00195
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 9, 2007
    Report Date
    May 15, 2007
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K890315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL AND COMPANION SAMPLES HAVE BEEN REQUESTED FOR EVAL. A F/U REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PT WAS SEEN FOR A DIALYSIS TREATMENT. THE TREATMENT WAS INITIATED AT 1030 WITH THE PT'S BLOOD PRESSURE (BP) OF 134/76. AT 1057 THE PT COMPLAINED OF SHORTNESS OF BREATH, WAS DIAPHORETIC AND WHEEZING. OXYGEN AT 2L/NASAL CANNULA (NC) WAS INITIATED. BENADRYL 25MG INTRAVENOUS PUSH (IVP) WAS GIVEN. THE BP AT THIS TIME WAS 84/52. THE BP IMPROVED TO 151/78 AFTER THE BENADRYL WAS GIVEN. THE PT IMPROVED WITH A DECREASE IN WHEEZING AND IMPROVED COLOR. THE PHYSICIAN ORDERED BENADRYL 25MG IVP TO BE GIVEN PRIOR TO USE OF EACH NEW DIALYZER. THE DIALYSIS TREATMENT WAS CONTINUED WITH A FLOW RATE AT 200ML/MIN. THE PT WAS ABLE TO CONTINUE THE TREATMENT WITH THE SAME DIALYZER W/O FURTHER MEDICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (CT190G) HOLLOW FIBER DIALYZER KDI NIPRO CORPORATION 07A25DX

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention BRAUN ARTERIAL| VENOUS BLOOD LINE TUBING SET| BRAUN DIALOG MACHINE