BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 10064418 · Received May 18, 2020

    Report

    Report Number
    9616066-2020-01672
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 19, 2020
    Report Date
    April 27, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403227974
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: EVENT DATE. THE CUSTOMER'S REPORT THAT PRIMARY TUBING SET LEAKED WAS NOT CONFIRMED. VISUAL INSPECTION SHOWED NO ANOMALIES. FUNCTIONAL TESTING SHOWED NO ANOMALIES. DIMENSIONAL ANALYSIS OF THE PRIMARY SET'S MALE LUER COMPONENT WAS MEASURED TO BE WITHIN ISO SPECIFICATION. THE ROOT CAUSE OF THE CUSTOMER'S REPORT WAS NOT IDENTIFIED. THE DEVICE HISTORY RECORD FOR MODEL 2433-0007 LOT 19096973 SHOWS THE SET WAS MANUFACTURED ON 30SEP2019 WITH A TOTAL OF 4,583 UNITS BUILT. THERE WERE NO QUALITY NOTIFICATIONS ISSUED DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE HOI MED SURGICAL FLOOR THAT A PRIMARY TUBING SET LEAKED. THERE WAS NO REPORT OF HARM TO THE PATIENT OR ANY MEDICAL PROFESSIONAL.

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE HOI MED SURGICAL FLOOR THAT A PRIMARY TUBING SET LEAKED. THERE WAS NO REPORT OF HARM TO THE PATIENT OR ANY MEDICAL PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528159 ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR FPA CAREFUSION 2433-0007 19096973 10885403227974

    Patients

    Seq Age Sex Outcome Treatment
    1 30262E, TD: UNK.| 30262E, TD: UNK.