BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING SET

    MDR report key: 11853231 · Received May 19, 2021

    Report

    Report Number
    2243072-2021-01507
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    February 20, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D2: MEDICAL DEVICE BRAND NAME: AS LVP 20D 2SS CV, D4: CATALOG #: 2420-0007, D4: UDI #: (B)(4), G.5. PMA / 510(K)#: K944320. H6: INVESTIGATION SUMMARY: ONE PRIMARY TUBING AND ONE SECONDARY TUBING WAS RETURNED BY THE CUSTOMER. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE PRIMARY TUBING WAS PRIMED AND FILLED WITH WATER. THE SECONDARY TUBING WAS PRIMED AND FILLED WITH BLUE DYE WATER AND CONNECTED TO THE PRIMARY TUBING SMARTSITE. THE SYSTEM WAS ALLOWED TO FLOW. NO BACKFLOW WAS OBSERVED. THE PRIMARY TUBING WAS INFUSED WITH AN ALARIS PUMP FOR 125 ML/HR FOR 1 HR. NO OVERINFUSION WAS OBSERVED. THE CUSTOMER COMPLAINT THAT THE POTASSIUM APPEARED TO INFUSE TO QUICKLY COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE POTASSIUM CHLORIDE INFUSED TOO QUICKLY THROUGH THE UNSPECIFIED BD¿ TUBING SET DUE TO A CHECK VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POTASSIUM APPEARED TO INFUSE TOO QUICKLY. TESTED CARRIER FLUID AND DETECTED HIGHER CONCENTRATION OF KCL THAT EXPECTED. SUSPECT BACK CHECK VALVE FAILURE." HERE ARE THE DETAILS: RL 261637. EVENT: POTASSIUM APPEARED TO INFUSE TOO QUICKLY. TESTED CARRIER FLUID AND DETECTED HIGHER CONCENTRATION OF KCL THAT EXPECTED. SUSPECT BACK CHECK VALVE FAILURE. WHAT WAS THE DATE AND TIME OF EVENT? 2/20/2021 @1445. WHAT FACILITY DID THIS OCCUR AT? (B)(6) HOSPITAL. DID THIS EVENT OCCUR DURING PATIENT USE? YES. PATIENT DEMOGRAPHICS (INITIALS, AGE, SEX, WT, DX, PERTINENT HX): N.C., 48 Y.O. FEMALE, 78.6 KG, DX: SHOCK HX: N/A. IF POSSIBLE, PLEASE PROVIDE MATERIAL NUMBER AND LOT NUMBER OF TUBING INVOLVED: UNKNOWN. ARE YOU ABLE TO SEND THE TUBING INVOLVED IN FOR INVESTIGATION? YES. MEDICATION INVOLVED: POTASSIUM CHLORIDE. SIZE OF CONTAINER: 100 ML. WAS THERE ANY HARM TO THE PATIENT? NONE DETECTED.

    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. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POTASSIUM CHLORIDE INFUSED TOO QUICKLY THROUGH THE UNSPECIFIED BD¿ TUBING SET DUE TO A CHECK VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POTASSIUM APPEARED TO INFUSE TOO QUICKLY. TESTED CARRIER FLUID AND DETECTED HIGHER CONCENTRATION OF KCL THAT EXPECTED. SUSPECT BACK CHECK VALVE FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744518 UNSPECIFIED BD TUBING SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR