BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE SET NON-VENTED BLOOD SET

    MDR report key: 12089325 · Received June 29, 2021

    Report

    Report Number
    2243072-2021-01779
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 2, 2021
    Report Date
    September 27, 2021
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 AN ALARIS PUMP MODULE SET NON-VENTED BLOOD SET EXPERIENCED LEAKS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "TUBING THAT HAD BLOOD IN IT AND WAS LEAKING UNKNOWN MATERIAL NUMBER AND LOT NUMBER". D.1. MEDICAL DEVICE BRAND NAME: ALARIS PUMP MODULE SET NON-VENTED BLOOD SET. D.3. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). D.4. MEDICAL DEVICE CATALOG #: 2477-0007. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 6/2/2021. G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. (TIJUANA). G.4. PMA / 510(K)#: K894842. H.6. INVESTIGATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. UNKNOWN SAMPLE WAS IDENTIFIED TO BE MODEL 2477-0007. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS PRIMED WITH SALINE. THE SET WAS SUCCESSFULLY PRIMED AND NO LEAKS OR DEFECTS WERE OBSERVED. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALARIS PUMP MODULE SET NON-VENTED BLOOD SET EXPERIENCED LEAKS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "TUBING THAT HAD BLOOD IN IT AND WAS LEAKING UNKNOWN MATERIAL NUMBER AND LOT NUMBER".

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD DEVICE EXPERIENCED LEAKS DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "TUBING THAT HAD BLOOD IN IT AND WAS LEAKING UNKNOWN MATERIAL NUMBER AND LOT NUMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983628 ALARIS PUMP MODULE SET NON-VENTED BLOOD SET INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1