BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IV 15' CABLE FOR USE WITH DISPOSABLE TRANSDUCER REUSABLE: DO NOT DISCA

    MDR report key: 24923505 · Received April 20, 2026

    Report

    Report Number
    1713468-2026-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DRS
    UDI-DI
    00887709127616
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, HAS NOT BEEN RECEIVED. D4 - PRIMARY UDI NUMBER: EXPIRY DATE IS UNKNOWN (B)(6).

    Description of Event or Problem · 0

    AN EVENT INVOLVING A TRANSPAC IV 15' CABLE WAS REPORTED IN WHICH ABP READINGS WERE NORMAL AT 00:48 (111/61) WITH NO OBSERVED ISSUES. AT 00:49, THE ARTERIAL BLOOD PRESSURE (ABP) READING SUDDENLY INCREASED WITHOUT CLINICAL CORRELATION OR IDENTIFIABLE EXTERNAL CAUSE. THE REGISTERED NURSE (RN) NOTED AN UPWARD BASELINE DRIFT IN THE ABP WHILE WAVEFORM AMPLITUDE AND INCREMENTS REMAINED NORMAL, AND THE ABP VALUES WERE INCONSISTENT WITH NON-INVASIVE BLOOD PRESSURE (NIBP) READINGS (NIBP 93/53 VS. ABP 173/137). TROUBLESHOOTING WAS PERFORMED, INCLUDING ATTEMPTS TO ZERO THE ARTERIAL LINE, WHICH WERE UNSUCCESSFUL DUE TO AN ERROR MESSAGE. THE TRANSDUCER WAS REPLACED, BUT THE ISSUE PERSISTED. AT 00:58, REPLACEMENT OF THE TRANSDUCER CABLE CONNECTED TO THE X3 RESOLVED THE ISSUE, INDICATING THE CABLE WAS THE LIKELY CAUSE. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984869 TRANSPAC® IV 15' CABLE FOR USE WITH DISPOSABLE TRANSDUCER REUSABLE: DO NOT DISCA TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL, INC. 10223729 00887709127616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown