BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14515640 · Received May 26, 2022

    Report

    Report Number
    3012307300-2022-09693
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Report Date
    May 26, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517184235
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LABOR PATIENT WHO RECEIVED AN EPIDURAL, WHO INITIALLY WAS VERY COMFORTABLE, AFTER 2 HOURS WAS UNCOMFORTABLE. REVIEWING THE PUMP LOG, THE PATIENT HAD REQUESTED AND RECEIVED TWO PCEA BOLUSES WITHOUT IMPROVEMENT TO HER PAIN. IN ORDER TO RULE OUT POTENCY PROBLEMS WITH THE INFUSION BAG, THE HEALTHCARE PROFESSIONAL PULLED A DOSE FROM A SEPARATE VIAL, AND THE PATIENT WAS COMFORTABLE AGAIN WITHIN MINUTES. ASSUMING THE PROBLEM WAS WITH THE INFUSION BAG, THE HEALTHCARE PROFESSIONAL STARTED TO CHANGE IT OUT FOR A NEW ONE, BUT IMMEDIATELY NOTICED THAT THE ORIGINAL BAG WAS STILL FULL. ACCORDING TO THE PUMP LOG, THE PATIENT SHOULD HAVE RECEIVED NEARLY HALF THAT BAG. AFTER THIS, THE HEALTHCARE PROFESSIONAL SWITCHED EVERYTHING OUT, INCLUDING BAG, TUBING, AND PUMP. THE PATIENT WENT ON TO DELIVER WITH ADEQUATE ANALGESIA. THE HEALTHCARE PROFESSIONAL WENT ON TO ASSESS WHETHER THE CARTRIDGE WAS INSTALLED AND LOCKED CORRECTLY. THE HEALTHCARE PROFESSIONAL RE-INSTALLED THE CARTRIDGE SEVERAL TIMES WITHOUT IMPROVEMENT, SO THE HEALTHCARE PROFESSIONAL SWITCHED TO A NEW TUBING SET. THIS SOLVED THE PROBLEM. THE ANESTHESIA PROVIDERS WERE MADE AWARE OF THE INCIDENT, AT THE TIME IT OCCURRED, AND WERE ASKED TO BE EXTRA VIGILANT IN ASSESSING THE PUMP TUBING PRIOR TO CONNECTING TO THE PATIENT. BEFORE THIS INCIDENT, IT WAS NOT IN THE HEALTHCARE PROFESSIONAL'S PRACTICE TO PRIME THE TUBING WITH THE PUMP, BUT RATHER VIA MANUAL PRESSURE ON THE BAG. AFTER THIS INCIDENT, THE HEALTHCARE PROFESSIONAL STARTED TO PRIME THE TUBING WITH THE PUMP IN ORDER TO IDENTIFY ANY DEFECTIVE TUBING/CARTRIDGES. SINCE STARTING THIS PRACTICE, TWO MORE SETS OF TUBING FROM THE SAME LOT NUMBER (4230892) THAT ARE DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711448 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7349-24 4230892 15019517184235

    Patients

    Seq Age Sex Outcome Treatment
    1 Female