BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 16752555 · Received April 17, 2023

    Report

    Report Number
    1416980-2023-01797
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: 2C1008KP (PREVIOUSLY SUBMITTED AS 2C2008K). G4: PMA/510K # OR BLA #: K071222 (PREVIOUSLY SUBMITTED AS NA). H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE PHOTOGRAPH WAS VISUALLY INSPECTED WHICH ONLY SHOWED AN IMAGE OF THE PRODUCT POUCH INSERT. THEREFORE, EVIDENCE OF THE REPORTED CONDITION COULD NOT BE VISUALIZED IN THE PHOTOGRAPH. THE REPORTED CONDITION WAS NOT VERIFIED. 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.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDERINFUSED; THE INFUSION TIME WAS OVER 7 DAYS. THIS WAS OBSERVED DURING PATIENT USE. ADDITIONALLY, A LEAK WAS NOTED DURING USE OF THE DEVICE WITH A NON-BAXTER NEEDLE SET. 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
    2259207 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 20K001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PORT-A-CATH| SAFESTEP HUBER NEEDLE SET