BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE SET, EM2400

    MDR report key: 15183767 · Received August 8, 2022

    Report

    Report Number
    1416980-2022-04094
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO A1: PATIENT IDENTIFIER: NONE (PREVIOUSLY SUBMITTED AS UNKNOWN). CORRECTION MADE TO B5: THERE WAS NO PATIENT INVOLVEMENT (PREVIOUSLY SUBMITTED AS THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT). CORRECTION MADE TO D1: BRAND NAME: VALVE SET, EM2400 (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO D4: CATALOGUE #: H938724 (PREVIOUSLY SUBMITTED AS ASKU). F10/H6: HEALTH EFFECT - IMPACT CODES: REPLACE F26 WITH F27. CORRECTION MADE TO G1: THE DEVICE WAS MANUFACTURED AT ONE OF THE FOLLOWING FACILITIES: BAXTER HEALTHCARE - ENGLEWOOD, 14445 GRASSLANDS DR, ENGLEWOOD CO 80112, UNITED STATES; AVAILMED, C. INDUSTRIAL LT. 001 MZ. 105, NO 20905 INT A, COL CD IND., TIJUANA, BAJA CALIFORNIA 22444, MEXICO. CORRECTION MADE TO G4: PMA/510K #: K002705 (PREVIOUSLY SUBMITTED AS NI). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EM2400 VALVE SET HAD A FINAL BAG DISCREPANCY. THE CUSTOMER STATED THAT THERE WAS A ¿VISCOSITY OF CLINOLIPID¿ FOR THE POTENTIAL INCONSISTENCY. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP OF COMPOUNDING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2371161 VALVE SET, EM2400 SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown