BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 65050 · Received January 23, 1997

    Report

    Report Number
    3019627-1997-00005
    Event Type
    Other
    Date Received
    January 23, 1997
    Date of Event
    January 4, 1997
    Report Date
    January 22, 1997
    Manufacturer
    ALTHIN MED, INC. PORTLAND SITE
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROX ONE HOUR INTO A DIALYSIS TREATMENT, THE VENOUS BLOODLINE BECAME DISCONNECTED FROM THE VENOUS NEEDLE. THE PT NOTICED THE PROBLEM AND CALLED FOR THE NURSE. THE NURSE STOPPED THE BLOOD PUMP AND CLAMPED THE LINE CLAMP. STAFF ALLEGED THAT THE MACHINE DID NOT ALARM. STAFF RETURNED THE EXTRACORPOREAL BLOOD TO THE PT, REPLACED THE BLOODLINES AND RESTARTED TREATMENT. STAFF GAVE TH PT 200 ML. NORMAL SALINE. TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PT WAS RELEASED AFTER THE INCIDENT. THE PT HAS HAD NO ADD'L PROBLEMS RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP ALTHIN MED, INC. PORTLAND SITE SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other NMC 16 GAUGE ACCESS NEEDLES #06945, NMC BLOODLINE| SET CATALOGHE #97-5270-00, FRESENIUS F-8 DIALYZER.