BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14567550 · Received June 1, 2022

    Report

    Report Number
    3012307300-2022-10342
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586029653
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE DID NOT INFUSE AND THE CLINICIAN HAD TO RESET THE CASSETTE AND THEN THE INFUSION STARTED. NO ALARM SOUNDED TO STATE THAT INFUSION WAS NOT RUNNING. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER ON (B)(6) 2022 AND ATTACHED BY ICU MEDICAL IN COMPLAINT: WE EXPERIENCED A PUMP RECORDING DELIVERY OF MEDICATIONS YET NOT ACTUALLY DELIVERING THE MEDICATIONS. WHEN WE CHANGED THE SET, WORKED AGAIN. WE SUSPECT THAT THERE MAY BE AN ISSUE WITH THE SETS. THE PUMP SERIAL NUMBER IS (B)(4). THE SET LOT NUMBERS ON SITE ARE LOT 4248632 AND LOT 4232350. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER ON (B)(6) 2022 AND ATTACHED BY ICU MEDICAL IN COMPLAINT: WE HAVE ANOTHER SET (LOT 4232350) THAT SEEMS TO HAVE A SIMILAR ISSUE. WHEN PRIMING, THE PUMP SOUNDS LIKE IT IS ACTIVE BUT NO FLUID IS COMING OUT AND IT IS RECORDING THE VOLUME. THE SET WAS REPLACED ON THE SAME PUMP AND IT WORKED PROPERLY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER (CHIEF, DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE) ON (B)(6) 2022 AND ATTACHED BY ICU MEDICAL IN COMPLAINT; I AM ASSUMING IT IS AN ISSUE WITH THE TUBING SETS THEMSELVES AND I WOULD ASSUME WE ARE NOT ALONE WITH THIS ISSUE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731674 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7324-01 4232350 10610586029653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown