BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPEATER

    MDR report key: 20065148 · Received August 26, 2024

    Report

    Report Number
    1416980-2024-04494
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    January 10, 2024
    Report Date
    May 8, 2025
    Manufacturer
    BAXTER CORPORATION ENGLEWOOD
    Product Code
    NEP
    UDI-DI
    00085412476698
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO H4, H6, H11. H4: THE LOT WAS MANUFACTURED BETWEEN MARCH 28, 2022 AND MARCH 30, 2022. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, TWO (2) PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THE VENT FILTER CAP CAME APART FROM THE SPIKE VENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRIFURCATED FLUID TRANSFER TUBE SET HAD THE FILTER OF A SPIKE KNOCKED OFF WHEN CHANGING A BAG OF SEMI-FINISHED PRODUCT. THIS OCCURRED DURING SETUP. ADDITIONALLY, THE HOSE CLAMP WAS NOT TIGHT ENOUGH AND THE BAGS EMPTIED THROUGH THE OPEN CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480895 REPEATER SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER CORPORATION ENGLEWOOD H93863 60357825 00085412476698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown