BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER- CONTINU FLO

    MDR report key: 163074 · Received April 3, 1998

    Report

    Report Number
    MW1013529
    Event Type
    Injury
    Date Received
    April 3, 1998
    Date of Event
    March 11, 1998
    Report Date
    April 3, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR ON 06/15/1998: ON FURTHER INVESTIGATION WITH THE RPTR AT THE ACCOUNT, WRITER WAS REFERRED TO ANOTHER PERSON. THE OTHER STAFF PERSON CLARIFIED THE SITUATION AND STATED THAT THE COMPLAINT SHOULD HAVE BEEN ON PRODUCT CODES 2C5521 AND 2C5526 WHICH HAD PREVIOUSLY BEEN REPORTED TO BAXTER. STATES THE ABOVE PRODUCT WAS REMOVED FROM THE ACCOUNT AND REPLACED WITH PRODUCT CODE 2C6537. THE OTHER STAFF PERSON REITERATED THAT MEDWATCH #1013529 WAS NOT CORRECT. 30 DAY MDRS WERE FILED ON PRODUCT CODES 2C5521 AND 2C5526 ON MARCH 27, 1998 (MEDWATCH #6000001-1998-00217 AND #6000001-1998-216).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER- CONTINU FLO I.V. TUBING FPA BAXTER HEALTHCARE CORP. 2C6537S *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention