BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ART PILLOW 8 MM PUMP SEGMENT UNIVERSA

    MDR report key: 87810 · Received April 25, 1997

    Report

    Report Number
    8030665-1997-00391
    Event Type
    Injury
    Date Received
    April 25, 1997
    Report Date
    April 9, 1997
    Manufacturer
    ERIKA DE REYNOSA CARE, INC.
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES HEMOLYSIS. REPORT INDICATES THAT AFTER 2 1/2 HOUR OF DIALYSIS TREATMENT, A KINK WAS NOTED AT THE DIALYZER END OF THE ARTERIAL LINE. THE LINE WAS REPOSITIONNED AND TAPED TO REMOVE THE KINK. A BLOOD SAMPLE WAS SENT FOR HEMOLYSIS EVALUATION FOLLOWING PATIENT'S COMPLAINT OF CHEST PAIN AND FEELING HOT. THE RESULT: POSITIVE. PATIENT WAS SENT TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. UPON PHONE CONVERSATION, STAFF REPORTED THAT PATIENT SPENT TWO DAYS IN HOSPITAL THEN WAS DISCHARGED; IS AT THIS TIME RECEIVING DIALYSIS TREATMENT WITHOUT PROBLEM. DOCTOR'S REPORT STATES: "PT HAS HAD PROBLEMS WITH HER ACCESS IN THE PAST AND IT WILL BE CHECKED AS A POSSIBLE CONTRIBUTER TO HEMOLYSIS". IMMEDIATE SUPERVISOR COMMENTED THAT VITAL SIGNS WERE LATE IN BEING OBTAINED. IF DONE ON TIME AND THE KINK WAS THERE IT COULD HAVE BEEN CORRECTED. FACILITY REPORT SAID THEY WERE NOT SURE IF IT WAS THE ARTERIAL OR THE VENOUS LINE THAT HAD THE KINK. A REPORT WILL BE FILED ON THE VENOUS LINE ALSO. IN SERVICE GIVEN TO STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ART PILLOW 8 MM PUMP SEGMENT UNIVERSA BLOODLINE FJK ERIKA DE REYNOSA CARE, INC. * R6N091

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R NMC VENOUS LINE0373035-F8 DIALYZER USE#3- MEDISYSS