BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 11639371 · Received April 8, 2021

    Report

    Report Number
    2243072-2021-01051
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 11, 2021
    Report Date
    July 15, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    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 SODIUM PHOSPHATE TOO QUICKLY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""I'M EMAILING TO REPORT A NEW SUSPECTED OVER-INFUSION OR BACK CHECK VALVE FAILURE:" "SECONDARY INFUSION OF SODIUM PHOSPHATE 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). D.4. MEDICAL DEVICE CATALOG#: 2420-0007. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). G.4. PMA / 510(K)#: K944320. H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THE SET WAS PRIMED WITH SALINE AND A BD SECONDARY SET FILLED WITH BLUE DYE WATER WAS ATTACHED. THE SETS WERE ALLOWED TO FREE FLOW. BLUE DYE WAS OBSERVED TO GO UP THE PRIMARY SET. THE CUSTOMER COMPLAINT THAT THERE IS A SUSPECTED OVER-INFUSION OR BACK CHECK VALVE FAILURE WAS VERIFIED. THE BACK CHECK VALVE WAS SENT TO THE SUPPLIER AND THEY WERE UNABLE TO DETERMINE A ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS LVP 20D 2SS CV INFUSED SODIUM PHOSPHATE TOO QUICKLY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""I'M EMAILING TO REPORT A NEW SUSPECTED OVER-INFUSION OR BACK CHECK VALVE FAILURE:" "SECONDARY INFUSION OF SODIUM PHOSPHATE 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¿ PUMP SET INFUSED SODIUM PHOSPHATE TOO QUICKLY DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""I'M EMAILING TO REPORT A NEW SUSPECTED OVER-INFUSION OR BACK CHECK VALVE FAILURE:" "SECONDARY INFUSION OF SODIUM PHOSPHATE INFUSED MUCH FASTER THAN EXPECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530236 AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1