BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO T 220 DIALYZER - USE #4 & #5

    MDR report key: 20535 · Received December 2, 1994

    Report

    Report Number
    2243621-1994-05302
    Event Type
    Injury
    Date Received
    December 2, 1994
    Date of Event
    September 20, 1994
    Report Date
    October 27, 1994
    Manufacturer
    TERUMO CORP.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT RECEIVED HIS THIRD DOSE OF IN-FED (100 MG) FIVE MINUTES LATER HE COMPLAINED OF CHILLS AND HIS TEMPERATURE WENT UP TO 104.3 F FROM 98.8. BLOOD CULTURES WERE DRAWN. THE PHYSICIAN WAS NOTIFIED AND TYLENOL GIVEN. THE TREATMENT WAS DISCONTINUED AND THE PT WENT TO THE ER BUT WAS NOT ADMITTED. ON 9/22/ HE WAS ADMITTED AGAIN GIVEN 100 MG IN-FED AND FIVE MINUTES LATER HE COMPLAINED OF CHILLS. HIS TEMP. WENT UP TO 101.7 FROM 98.1. HE REFUSED TO CONTINUE HIS TREATMENT AND WENT HOME. HE CAME BACK ON THE 24TH AND DID NOT RECEIVE IN-FED. HE HAD AN UNNEVENTFUL TREATMENT. THE PHYSICIAN CHANGED THE PT TO A CAAA 170 DIALYZER AND DISCONTINUED REUSE FOR THIS PT.THE DR. LATER SAID THAT THE EVENTS WERE RELATED TO THE IN-FED. THE PT'S CHART IS NOW MARKED THAT HE IS ALERGIC TO IN-FED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO T 220 DIALYZER - USE #4 & #5 DIALYZER FJI TERUMO CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O BAXTER 550 UF DIALYSIS MACHINES.