BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ SMARTSITE¿ GRAVITY SET

    MDR report key: 16219421 · Received January 20, 2023

    Report

    Report Number
    9616066-2023-00039
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 29, 2022
    Report Date
    April 4, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A COMPLAINT OF SOLUTION LEAKING OUT DUE TO DRIP CHAMBER SEPARATING WAS RECEIVED FROM THE CUSTOMER. PHOTOS OF THE PACKAGING AS WELL AS THE SEPARATED SET WERE SENT BY THE CUSTOMER. THE DEFECT WAS CONFIRMED. TUBING SEPARATED AT THE DRIP CHAMBER, AND DOES NOT SEEM TO BE DAMAGED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL CM42500E-07 BECAUSE THE LOT NUMBER IS UNKNOWN. A TREND FOR THIS SEPARATION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. CM42500E-07 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 42500E-07. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT: K931173. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING CAME APART AT THE DRIP CHAMBER AND LEAKED OUT MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS DURING PREP FOR A CASE SO THERE WAS NO PATIENT INVOLVEMENT. I SPIKED THE IV BAG WITH THE TUBING AND AS I HUNG THE BAG ON THE IV POLE THE SOLUTION CAME POURING OUT BECAUSE THE TUBING HAD COME APART AT THE BOTTOM OF THE DRIP CHAMBER".

    Description of Event or Problem · 0

    HOLD FOR CS 02.03IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET TUBING CAME APART AT THE DRIP CHAMBER AND LEAKED OUT MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS DURING PREP FOR A CASE SO THERE WAS NO PATIENT INVOLVEMENT. I SPIKED THE IV BAG WITH THE TUBING AND AS I HUNG THE BAG ON THE IV POLE THE SOLUTION CAME POURING OUT BECAUSE THE TUBING HAD COME APART AT THE BOTTOM OF THE DRIP CHAMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005072 BD ALARIS¿ SMARTSITE¿ GRAVITY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown