BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSDUCER FILTER (DBL SLIP)

    MDR report key: 36328 · Received August 26, 1996

    Report

    Report Number
    54354-1996-00252
    Event Type
    Injury
    Date Received
    August 26, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 14, 1996
    Manufacturer
    GELMAN SCIENCES INC
    Product Code
    FKJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT APPROX. FOUR HOURS AFTER INITIATION OF HEMODIALYSIS TREATMENT THE PT'S VENOUS NEEDLE DISLODGED AND BLOOD WAS NOTED ON THE FLOOR. THE BLOOD PUMP WAS STOPPED; THE LINES CLAMPED. THE PT WAS SLEEPING AT THE TIME OF THE EVENT AND WAS BELIEVED TO HAVE JERKED HIS ARM. THE PT WAS AROUSABLE AND THEN LOST CONSCIOUSNESS FOR SEVERAL SECONDS. THE PT RESPONDED TO A SALINE BOLUS AND WAS ALERT AND ORIENTED. THE PT WAS TRANSFERRED TO THE HOSP EMERGENCY ROOM, WAS SEEN AND RELEASED. EBL 500CC. FACILITY STATED THAT THE VENOUS PRESSURE ALARM DID NOT GO OFF AT THE TIME OF THE EVENT. HOWEVER, THE VENOUS PRESSURE MONITORING TRANSDUCER PROTECTOR WAS NOTED TO BE BLOODY AT THE TIME OF THE EVENT AND MAY NOT HAVE BEEN MONITORING PROPERLY. THE FACILITY ALSO STATED THAT THEY HAVE BEEN HAVING PROBLEMS WITH THE TP'S BACKING UP. ANOTHER CO'S HEMO MACHINE WAS PULLED AND CHECKED AND ALL THE ALARMS FUNCTIONED PROPERLY. THE FACILITY ALSO STATED THAT THEY ARE NOT SURE WHAT CAUSED THE PROBLEM. THE PT RETURNED TO THE CLINIC FOR TREATMENT ON 8/8/96 WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSDUCER FILTER (DBL SLIP) * FKJ GELMAN SCIENCES INC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization