BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10963166 · Received December 7, 2020

    Report

    Report Number
    9616066-2020-20537
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    August 15, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE SAMPLE OF WAS RECEIVED FOR QUALITY INVESTIGATION. THE SAMPLE WAS CONNECTED TO A SYRINGE AND PRIMING ATTEMPTED, HOWEVER, NO FLOW WAS ALLOWED THROUGH THE SAMPLE. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 20075210 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 01JUL2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT OF THE TUBING DEFECTIVE / DAMAGED WAS VERIFIED BY TESTING. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE OF THE ISSUE WAS A VENDOR SUPPLIED COMPONENT WAS NOT MANUFACTURED CORRECTLY. RATIONALE: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE WAS BLOCKED/OCCLUDED AND WOULD NOT PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WILL NOT PRIME LINE MEETS RESISTANCE BEFORE DISC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428717 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 20075210 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1