BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 11064824 · Received December 23, 2020

    Report

    Report Number
    2016493-2020-77514
    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 A VOLUME ACCURACY PROBLEM COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED FOR INVESTIGATION. NO DEVICE HISTORY SEARCH WAS PERFORMED SINCE NO SOURCE DEVICE SERIAL NUMBER WAS REPORTED BY THE CUSTOMER. A REVIEW OF THE FEBRUARY 2021 COMPLAINT REVIEW BOARD (CRB) DID NOT FIND AN INCREASING TREND FOR THE REPORTED ISSUE OF ¿VOLUME ACCURACY PROBLEM¿. BASED ON THE CRB REVIEW AND THE LIMITED INFORMATION PROVIDED NO FURTHER INVESTIGATION ACTIONS WILL BE PERFORMED. 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 PCUNIT, SYRINGE PUMP MODULE, AND AUTO ID MODULE WERE INVOLVED IN AN UNSPECIFIED "HEALTH EFFECT MEDICAL DEVICE PROBLEM." THE EVENT DESCRIPTION PROVIDED WAS "F26 - NO HEALTH CONSEQUENCES OR IMPACTE2401 - INSUFFICIENT INFORMATIONA140304 - VOLUME ACCURACY PROBLEMA26 - INSUFFICIENT INFORMATIONB01 - TESTING OF ACTUAL/SUSPECTED DEVICEB17 - DEVICE NOT RETURNEDC20 - NO FINDINGS AVAILABLEC21 - RESULTS PENDING COMPLETION OF INVESTIGATIOND14 - NO PROBLEM DETECTEDD15 - CAUSE NOT ESTABLISHED." 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 (B)(6) LAW COMPLIANCE, HEALTH (B)(6) MEDICAL DEVICES ONLINE DATABASE RECENTLY UPLOADED REPORTS THAT THEY RECEIVED SINCE JUNE 2020. IT WAS REPORTED THAT AN ALARIS PCUNIT, SYRINGE PUMP MODULE, AND AUTO ID MODULE WERE INVOLVED IN AN UNSPECIFIED "HEALTH EFFECT MEDICAL DEVICE PROBLEM." THE EVENT DESCRIPTION PROVIDED WAS "F26 - NO HEALTH CONSEQUENCES OR IMPACT E2401 - INSUFFICIENT INFORMATION A140304 - VOLUME ACCURACY PROBLEM A26 - INSUFFICIENT INFORMATION B01 - TESTING OF ACTUAL/SUSPECTED DEVICE B17 - DEVICE NOT RETURNED C20 - NO FINDINGS AVAILABLE C21 - RESULTS PENDING COMPLETION OF INVESTIGATION D14 - NO PROBLEM DETECTED D15 - CAUSE NOT ESTABLISHED." NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO CONTACT INFORMATION OR PRODUCTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526692 ALARIS SYRINGE PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 8600,8015,SYR TUBE, TD UNK