BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 11882385 · Received May 26, 2021

    Report

    Report Number
    2243072-2021-01535
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 13, 2021
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE AS LVP 20D 2SS CV INFUSED VANCOMYCIN TOO QUICKLY DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SECONDARY INFUSION OF VANCOMYCIN INFUSED MUCH FASTER THAN EXPECTED." D.1. MEDICAL DEVICE BRAND NAME: AS LVP 20D 2SS CV. D.3. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). D.4. MEDICAL DEVICE CATALOG#: 2420-0007. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.4. PMA / 510(K)#: K944320. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/17/2021. H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH SALINE AND A BD SECONDARY SET WAS PRIMED WITH BLUE DYE WATER. THE SETS WERE ALLOWED TO FREEFLOW. NO BACKFLOW WAS OBSERVED. AN INFUSION RUN WAS SETUP WITH THE PRIMARY SET FOR 125 ML/HR FOR 1 HOUR USING ALARIS PUMP DCHU - 0010 WITH PUMP MODULE DCHU-0016 AND FLOWED INTO AN EMPTY BEAKER. AT THE END OF THE INFUSION RUN THE EMPTY BEAKER HAD APPROXIMATELY 125 ML/HR. THE CUSTOMER COMPLAINT THAT THE VANCOMYCIN INFUSED MUCH FASTER THAN EXPECTED 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 AS LVP 20D 2SS CV INFUSED VANCOMYCIN TOO QUICKLY DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SECONDARY INFUSION OF VANCOMYCIN INFUSED MUCH FASTER THAN EXPECTED."

    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. 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 UNSPECIFIED BD¿ INFUSION SET INFUSED VANCOMYCIN TOO QUICKLY DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SECONDARY INFUSION OF VANCOMYCIN INFUSED MUCH FASTER THAN EXPECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786388 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1