BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10261196 · Received July 10, 2020

    Report

    Report Number
    9616066-2020-02221
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 18, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT SEND IN THE EXPECTED STANDALONE SMARTSITE MODEL 2000E LOT 20045797. THE CUSTOMER DID NOT SEND IN THE EVENT SMARTSITES THAT WOULD NOT FLUSH. A DEVICE HISTORY RECORD FOR MODEL 2000E WITH LOT NUMBER 20045797, WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4), UNITS IN 1 LOT NUMBER WERE BUILT ON 11APR2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE CUSTOMER¿S REPORT THAT THE PRODUCT WOULD NOT FLUSH WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A NURSE OPEN TWO DIFFERENT ONES TODAY THAT WOULD NOT FLUSH. THERE ARE NOW TWO LOT NUMBERS INVOLVED 1. (10) 20035833 (THIS INCIDENT REPORTED UNDER 9616066-2020-02193). 2. (10) 20045797. PER CUSTOMER EMAIL RESPONSE: WERE THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? IF YES, PLEASE PROVIDE DETAILS. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE DEFECT. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE REPORTED FAILURE OR DID IT OCCUR DURING PREPARATION/PRIMING? IT OCCURRED DURING PRIMING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A NURSE OPEN TWO DIFFERENT ONES TODAY THAT WOULD NOT FLUSH. THERE ARE NOW TWO LOT NUMBERS INVOLVED (10) 20035833 (THIS INCIDENT REPORTED UNDER 9616066-2020-02193), (10) 20045797. PER CUSTOMER EMAIL RESPONSE: WERE THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? IF YES, PLEASE PROVIDE DETAILS. THERE WERE NO ADVERSE EVENTS AS A RESULT OF THE DEFECT. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE REPORTED FAILURE OR DID IT OCCUR DURING PREPARATION/PRIMING? IT OCCURRED DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722213 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20045797 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4).| (B)(4).