BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 11064795 · Received December 23, 2020

    Report

    Report Number
    2016493-2020-77503
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    December 2, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE THAT THERE WAS INFUSION OR FLOW PROBLEM, INACCURATE DELIVERY, DEFECTIVE COMPONENT - PHYSICAL RESISTANCE / STICKING COULD NOT BE CONFIRMED. NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME, AND NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    PER VANESSA'S LAW COMPLIANCE, HEALTH CANADA'S MEDICAL DEVICES ONLINE DATABASE RECENTLY UPLOADED REPORTS THAT THEY RECEIVED SINCE JUNE 2020. IT WAS REPORTED THAT AN ALARIS LARGE VOLUME PUMP MODULE (LVP) WAS INVOLVED IN AN UNSPECIFIED HEALTH EFFECT MEDICAL DEVICE PROBLEM. THE EVENT DESCRIPTION PROVIDED WAS "E2401 - INSUFFICIENT INFORMATION F05 - DELAY TO TREATMENT/THERAPYA14 - INFUSION OR FLOW PROBLEM A140504 - INACCURATE DELIVERY A0202 - DEFECTIVE COMPONENT A0509 - PHYSICAL RESISTANCE / STICKING." NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO CONTACT INFORMATION OR PRODUCTS WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    PER VANESSA'S LAW COMPLIANCE, HEALTH (B)(4) MEDICAL DEVICES ONLINE DATABASE RECENTLY UPLOADED REPORTS THAT THEY RECEIVED SINCE (B)(6) 2020. IT WAS REPORTED THAT AN ALARIS LARGE VOLUME PUMP MODULE (LVP) WAS INVOLVED IN AN UNSPECIFIED "HEALTH EFFECT MEDICAL DEVICE PROBLEM." THE EVENT DESCRIPTION PROVIDED WAS "E2401 - INSUFFICIENT INFORMATION, F05 - DELAY TO TREATMENT/THERAPY, A14 - INFUSION OR FLOW PROBLEM, A140504 - INACCURATE DELIVERY, A0202 - DEFECTIVE COMPONENT, A0509 - PHYSICAL RESISTANCE / STICKING." NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO CONTACT INFORMATION OR PRODUCTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532261 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING,8015, TD UNK