BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 12193870 · Received July 19, 2021

    Report

    Report Number
    2243072-2021-01916
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    December 7, 2020
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A COMPLAINT OF A CLAMP NOT WORKING ON A SET WAS RECEIVED FROM THE CUSTOMER. NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF ISSUES WITH THE CLAMP COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET CLAMP WAS DAMAGED, RESULTING IN LEVOPHED TO FREE-FLOW TO THE PATIENT AND CAUSE HYPERTENSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN ROUNDING ON THE UNIT LAST WEEK, I WAS ASKED TO PROVIDE SPECIFIC INFORMATION REGARDING EVENTS. TODAY I CAME ACROSS ONE THAT HAPPENED IN (B)(6), AND RESULTED IN THE FREE FLOW OF LEVOPHED TO A PATIENT CAUSING PROFOUND HYPERTENSION. THE EVENT OCCURED ON (B)(6) 2020." "PT IS IN THE ICU. TRACH ON THE VENT AND ON FENT, LEVO, CARDENE. PT HAS BEEN ON AND OFF LEVO AND CARDENE ALL MORNING DUE TO BLOOD PRESSURE PARAMETERS AND ON HD AT THIS MOMENT- TRYING TO REMOVE 3L FLUID. AROUND 0920, BLOOD PRESSURE DROPPED TO SBP HIGH 80S. I STARTED LEVO AGAIN TO 1MCG/MIN AT THIS TIME BECAUSE I HAVE BEEN NOTICING THAT 3MCG/MIN HAS BEEN TOO MUCH AND WAS INCREASING BLOOD PRESSURE TOO FAST. AT 0930, PT WENT HYPERTENSIVE TO SBP 250S, HR 120S, MULTIPLE RUNS OF VTACH AND SATS WENT DOWN TO 79%. WENT MAX TO 100% ON THE VENT. LEVO OFF. CARDENE STARTED. RT AT THE BEDSIDE. I CALLED CHARGE IN AT BEDSIDE AS WELL BECAUSE AT THAT POINT- PT WAS MAXED OUT ON CARDENE AND GIVEN MULTIPLE BOLUSES OF FENTANYL DUE TO CHEST PAIN COMPLAINT BY PATIENT. PAGED MD TWICE. NO RESPONSE. I PULLED IV HYDRALAZINE 10MG OUT OF PYXIS. AS I WAS DISCONNECTING THE LEVO LINE TO GIVE THE HYDRALAZINE IN THAT LUMEN, I NOTICED THE LEVO WAS FLOWING STILL WITH EVEN THE PUMP TURNED OFF. DUE TO THIS SITUATION, THE PUMP WAS MALFUNCTIONING AND STILL FLOWING LEVO INTO PATIENT WHILE THE PUMP WAS TURNED OFF. WEANED CARDENE SLOWLY DOWN WHEN BLOOD PRESSURE BECAME STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089066 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1