BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 23975944 · Received January 6, 2026

    Report

    Report Number
    1416980-2026-00077
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D1/D4/G4: THE SET IS POTENTIALLY ONE OF THE FOLLOWING: BRAND NAME IS CLEARLINK, MODEL AND CATALOG NUMBER 2R8486, UDI# IS (B)(4). BRAND NAME IS CLEARLINK/DUO-VENT, MODEL AND CATALOG NUMBER 2R8480, UDI# IS (B)(4) 510K# IS K153158. E1: INITIAL REPORTER PHONE NO.(ADDITIONAL): (B)(6). THE DEVICES WERE NOT RETURNED AND THE LOT NUMBERS ARE 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 OVER-INFUSIONS WERE OBSERVED DURING USE OF THREE (3) UNSPECIFIED ACCESS SETS IN USE WITH SPECTRUM INFUSION PUMPS. THE INFUSIONS WERE EMPTYING SOONER THAN EXPECTED (APPROXIMATELY 1-3 HOURS). THE ISSUES OCCURRED WHILE THE PATIENTS WERE RECEIVING TOTAL PARENTERAL NUTRITION (TPN) VIA A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). 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
    34372 ASKU SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PICC| SPECTRUM INFUSION PUMP| TPN